510(k) summaries or 510(k) statements for...
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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD August 2015 DEVICE: SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEMSD BIOSENSOR, INC. 510(k) NO: K132929 (http://www.accessdata.fda.gov/cdrh_docs/pdf13/K132929.pdf)(Traditional)ATTN: Feng‐Yu Lee PHONE NO : 949 951‐3046 27001 LA PAZ RD, SUITE 266B SE DECISION MADE: 05‐AUG‐15MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI‐LIGHT, HI‐LIGHT PLUSDENTALL CORPORATION 510(k) NO: K140432 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K140432.pdf)(Traditional)ATTN: Priscilla Chung PHONE NO : 714 202‐5789 2651 E CHAPMAN AVE. SUITE 110 SE DECISION MADE: 03‐AUG‐15FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEECH, MEDICINALCAROLINA BIOLOGICAL SUPPLY CO. 510(k) NO: K140907 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K140907.pdf)(Traditional)ATTN: KEITH E BARKER PHONE NO : 336 584‐0381 2700 YORK RD. SE DECISION MADE: 07‐AUG‐15BURLINGTON NC 27215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K141017 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141017.pdf)(Traditional)ATTN: MARGARET MARSH PHONE NO : 210 255‐6481 6203 FARINON DRIVE SE DECISION MADE: 20‐AUG‐15SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Unimicro Trocar Kit, models: Auto‐Locking Trocar, Hasson Trocar, Bladeless TrocarUNIMICRO MEDICAL SYSTEMS (SHENZHEN510(k) NO: K141594 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141594.pdf)(Traditional)ATTN: LONG YANG PHONE NO : 86 755 86664986 R15‐08, EAST BUILDING, YIHAI PLAZASE DECISION MADE: 10‐AUG‐15
SHENZHEN, GUANGDONG CN 518054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 25‐Hydroxy Vitamin Ds EIAIMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K142351(Traditional)ATTN: Mick Henderson PHONE NO : 44 191 5190660 10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 25‐AUG‐15BOLDON, TYNE & WEAR GB NE35 9PD 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAL‐1F Blood Glucose Monitoring System, GAL‐1F Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. 510(k) NO: K142689 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142689.pdf)(Special)ATTN: Hsue‐mei Lee PHONE NO : 011 886 35641952 No. 7, Li‐Hsin Road V, Hsinchu SciSE DECISION MADE: 06‐AUG‐15Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acuzone Acupuncture Needles, KSC DB Plus Acupuncture NeedlesK.S. Choi Corporation 510(k) NO: K142760 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142760.pdf)(Traditional)ATTN: Kak Soo Choi PHONE NO : 323 2321600 179 W39th St SE DECISION MADE: 25‐AUG‐15Los Angeles CA 90037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TM SAFETY NEEDLEThinkMed Medical Technology Co., L510(k) NO: K142765 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142765.pdf)(Traditional)ATTN: Garfield Wang PHONE NO : 86 135647 51751 No.4 Building, 322 Hongyang Road, SE DECISION MADE: 11‐AUG‐15Kunshan CN 215341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd 510(k) NO: K142943 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142943.pdf)(Traditional)ATTN: Chen Hui PHONE NO : 86 0579 89119235 No.329 Yongkang Street SE DECISION MADE: 03‐AUG‐15Jinhua CN 321015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraTENSShenzhen Dongdixin Technology Co.,510(k) NO: K142976 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142976.pdf)(Traditional)ATTN: Qilian Liu PHONE NO : 086 075 527652471 No. 3 Building, XiLiBaimang IndustSE DECISION MADE: 26‐AUG‐15Shenzhen CN 518108 510(k) STATEMENT DEVICE: SOPIXSOPRO ‐ ACTEON GROUP 510(k) NO: K142995 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142995.pdf)(Traditional)ATTN: PHILIPPE BOYER PHONE NO : 011 33 442980101 SE DECISION MADE: 17‐AUG‐15LaCiotat FR 13705 510(k) STATEMENT DEVICE: Urgoclean Ag, Antibacterial Absorbent Wound Dressing with SilverLABORATOIRES URGO 510(k) NO: K143017 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143017.pdf)(Traditional)ATTN: SOPHIE FORTIN PHONE NO : 33380 442878 42 RUE DE LONGVIC SE DECISION MADE: 07‐AUG‐15CHENOVE FR 21300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disposable Pressure Manometer (DPM)Westmed, Inc. 510(k) NO: K143148 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143148.pdf)(Traditional)ATTN: DIANA UPP PHONE NO : 1 800 7242328 5580 S. Nogales Hwy. SE DECISION MADE: 11‐AUG‐15Tucson AZ 85706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AveCure Microwave Coagulation‐Ablation Generator, AveCure Microwave Large Antenna‐Probe, AveCure Microwave Medium Antenna‐Probe, AveCure Microwave Small Antenna‐Probe, AveCure Microwave Mini Antenna‐ProbeMEDWAVES INCORPORATED 510(k) NO: K143203 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143203.pdf)(Traditional)ATTN: TED ORMSBY PHONE NO : 1 858 9460015 16760 WEST BERNARDO DRIVE SE DECISION MADE: 26‐AUG‐15SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mitsar‐EEG
MITSAR CO., LTD 510(k) NO: K143233 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143233.pdf)(Traditional)ATTN: Semchenkov Ales PHONE NO : 7812 297 9013 Novorossiyskaya str. 21‐2 SE DECISION MADE: 13‐AUG‐15St. Petersburg RU 194021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON‐STERILE, POWER FREE NITRILE EXAMINATION GLOVES‐ORANGE, GREEN, BLUE AND VIOLET COLORYTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K143289 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143289.pdf)(Traditional)ATTN: Arivagalan Subramaniam PHONE NO : 60 5 6792288 LOT 1422‐1424, BATU 10 LEKIR SE DECISION MADE: 18‐AUG‐15SITIAWAN, PERAK MY 32020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TheraCal DCBisco Inc 510(k) NO: K143292 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143292.pdf)(Traditional)ATTN: Michelle Schiltz‐Taing PHONE NO : 847 5346146 1100 West Irving Park Road SE DECISION MADE: 04‐AUG‐15Schaumburg IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OC‐Light S FITEIKEN CHEMICAL CO. LTD 510(k) NO: K143325 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143325.pdf)(Traditional)ATTN: Yoshinori Ota PHONE NO : 81 3 58463479 4‐19‐9 TAITO SE DECISION MADE: 20‐AUG‐15TAITO‐KU JP 110‐8408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BC‐3600 Auto Hematology AnalyzerMINDRAY BIO‐MEDICAL ELECTRONICS CO510(k) NO: K143348 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143348.pdf)(Traditional)ATTN: Tan Chuanbin PHONE NO : 86 755 26582888 Mindray Building, Keji 12th Road SSE DECISION MADE: 21‐AUG‐15Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Natrelle 133 Plus Tissue ExpanderALLERGAN, INC. 510(k) NO: K143354 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143354.pdf)(Traditional)
ATTN: Bruce Krattenmaker PHONE NO : 1 714 2466182 2525 DUPONT DRIVE SE DECISION MADE: 20‐AUG‐15IRVINE CA 92623‐9534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UTAH CVX‐RIPEUTAH MEDICAL PRODUCTS, INC. 510(k) NO: K143424 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143424.pdf)(Traditional)ATTN: Ben Shirley PHONE NO : 1 800 5661200 7043 SOUTH 300 WEST SE DECISION MADE: 28‐AUG‐15MIDVALE UT 84047‐1048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dantec DCN Disposable Concentric Needle Electrodes‐25mm, Dantec DCN Disposable Concentric Needle Electrodes‐37mm, Dantec DCN Disposable Concentric Needle Electrodes‐50mm, Dantec DCN Disposable Concentric Needle Electrodes‐75mmNatus Manufacturing Limited 510(k) NO: K143433 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143433.pdf)(Traditional)ATTN: Michael Galvin PHONE NO : 353 091 630043 IDA Business Park SE DECISION MADE: 28‐AUG‐15Gort IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SynePure Wound CleanserSynedgen Inc. 510(k) NO: K143444(Traditional)ATTN: Shenda Baker PHONE NO : 909 4476858 1420 N. Claremont Blvd Apt.105D SE DECISION MADE: 21‐AUG‐15Claremont CA 91711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Accu‐Chek FlexLink Plus infusion setRoche Diagnostics GmbH 510(k) NO: K143446 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143446.pdf)(Traditional)ATTN: Alexander Ruegner PHONE NO : 49 621 7598395 Sandhofer Strasse 116 SE DECISION MADE: 13‐AUG‐15Mannheim DE 68305 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pruitt F3‐S Carotid ShuntLeMaitre Vascular, Inc 510(k) NO: K143454 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143454.pdf)(Traditional)ATTN: Xiang Zhang PHONE NO : 781 4251729 63 Second Avenue SE DECISION MADE: 27‐AUG‐15
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeurosplintNeurospectrum LLC 510(k) NO: K143458 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143458.pdf)(Traditional)ATTN: David Kernan PHONE NO : 844 7866484 3 Crown Crt SE DECISION MADE: 13‐AUG‐15Rancho Mirage CA 92270 510(k) STATEMENT DEVICE: Lifelines iEEGKVIKNA EHF 510(k) NO: K143487 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143487.pdf)(Traditional)ATTN: Gardar Thorvardsson PHONE NO : 354 578 8400 STORHOFOI 21 SE DECISION MADE: 21‐AUG‐15REYKJAVIK IS 110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ActiSpec Activity Monitor SLEEP MODUS, INC. 510(k) NO: K143512 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143512.pdf)(Traditional)ATTN: STANFORD P HUDSON PHONE NO : 214 4054055 1201 RICHARDSON DRIVE, SUITE 280‐BSE DECISION MADE: 26‐AUG‐15RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer MEDLINE INDUSTRIES, INC. 510(k) NO: K143529 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143529.pdf)(Traditional)ATTN: JENNIFER MASON PHONE NO : 847 6433652 ONE MEDLINE PLACE SE DECISION MADE: 21‐AUG‐15MUNDLELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecsys CA‐125 II assayROCHE PROFESSIONAL DIAGNOSTICS 510(k) NO: K143534 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143534.pdf)(Traditional)ATTN: LINDA MCCAMMACK PHONE NO : 1 317 5217144 9115 HAGUE ROAD SE DECISION MADE: 06‐AUG‐15INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRXperion MR Injection System, MRXperion MR Injection System Syringe KitBAYER MEDICAL CARE INC. 510(k) NO: K143538(Traditional)ATTN: LISA A. EWING PHONE NO : 724 8167297 1 BAYER DRIVE SE DECISION MADE: 14‐AUG‐15INDIANOLA PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dental Implant OKTAGON Bone LevelHager & Meisinger GmbH 510(k) NO: K143539 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143539.pdf)(Traditional)ATTN: Wiebke Stolten PHONE NO : 0049 02131 20120388 Hansemannstrasse 10 SE DECISION MADE: 31‐AUG‐15Neuss DE 41468 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Venus Legacy CXVenus Concept Ltd. 510(k) NO: K143554 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143554.pdf)(Traditional)ATTN: Orit Ron Edoute PHONE NO : 1 416 9070115 4556 N.Hiatus Road SE DECISION MADE: 04‐AUG‐15Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fujifilm Double Balloon Endoscopes Models EN‐530T and EN‐580TFUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K143556 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143556.pdf)(Traditional)ATTN: MARY MOORE PHONE NO : 973 6862627 10 HIGH POINT DR SE DECISION MADE: 20‐AUG‐15WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive Sterilization TraysNuVasive, Incorporated 510(k) NO: K143579 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143579.pdf)(Traditional)ATTN: Olga Lewis PHONE NO : 1 858 3205257 7475 Lusk Boulevard SE DECISION MADE: 28‐AUG‐15San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cathivex ¿GV filter unitsMERCK MILLIPORE LTD. 510(k) NO: K143583 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143583.pdf)(Traditional)
ATTN: CHRIS PARR PHONE NO : 3563 21 4532308 TULLAGREEN SE DECISION MADE: 11‐AUG‐15CARRIGTWOHILL IE EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PaxWire Occlusion Balloon SystemACCESSCLOSURE, INC. 510(k) NO: K143613 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143613.pdf)(Traditional)ATTN: Kelly Jabbal PHONE NO : 408 6106517 5452 Besty Ross Drive SE DECISION MADE: 14‐AUG‐15Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Narval BruxRESMED SAS 510(k) NO: K143623 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143623.pdf)(Traditional)ATTN: Larissa D'Andrea PHONE NO : 33 426 100371 292, ALLEE JACQUES, MONOD SE DECISION MADE: 13‐AUG‐15SAINT‐PRIEST CEDEX FR 69791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MAX Enteric Parasite Panel, BD MAX InstrumentBECTON, DICKINSON AND COMPANY 510(k) NO: K143648 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143648.pdf)(Traditional)ATTN: PAUL SWIFT PHONE NO : 410 3164905 7 LOVETON CIR. SE DECISION MADE: 25‐AUG‐15SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GranOSTM ‐ beta tricalcium phosphate synthetic bone granulesTCM ASSOCIATES LTD 510(k) NO: K143692 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143692.pdf)(Traditional)ATTN: IAIN ALLIGAN PHONE NO : 44 1992 892085 3, HILLGROVE BUSINESS PARK NASEINGSE DECISION MADE: 21‐AUG‐15NASEING ESSEX GB EN9 2HB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPAP CannulaideSalter Labs 510(k) NO: K143700 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143700.pdf)(Traditional)ATTN: Aurelia Brownridge PHONE NO : 760 7957100 2365 Camino Vida Roble SE DECISION MADE: 05‐AUG‐15Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUMVOLCANO CORPORATION 510(k) NO: K143701 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143701.pdf)(Traditional)ATTN: MARCUS GARCIA PHONE NO : 800 2284728 3721 Valley Centre Dr Ste 500 SE DECISION MADE: 26‐AUG‐15San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRCT2FX SOLUTIONS 510(k) NO: K143721 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143721.pdf)(Traditional)ATTN: JEAN JACQUES MARTIN PHONE NO : 33 47455 3535 1663 RUE DE MAJORNAS SE DECISION MADE: 27‐AUG‐15VIRIAT FR 01440 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitWILLIAM A. COOK AUSTRALIA PTY, LTD510(k) NO: K143724 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143724.pdf)(Special)ATTN: Gordana Pozvek PHONE NO : 61 73841 1188 95 BRANDL ST EIGHT MILE PLAINS SE DECISION MADE: 27‐AUG‐15BRISBANE AU QLD 4113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SterilContainer SAESCULAP, INC. 510(k) NO: K143729 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143729.pdf)(Traditional)ATTN: Denise R Adams PHONE NO : 610 9849076 3773 CORPORATE PARKWAY SE DECISION MADE: 18‐AUG‐15CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC 510(k) NO: K143738 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143738.pdf)(Traditional)ATTN: Jack Griffis PHONE NO : 404 5836889 6018 Eagles Rest Trail SE DECISION MADE: 27‐AUG‐15Sugar Hill GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Total Knee Application (TKA)MAKO SURGICAL CORP. 510(k) NO: K143752 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143752.pdf)(Traditional)ATTN: JONATHAN REEVES PHONE NO : 954 6280655 2555 DAVIE RD SE DECISION MADE: 06‐AUG‐15FT. LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerioType RapidCLINICAL HOUSE EUROPE GMBH 510(k) NO: K143758 (http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143758.pdf)(Traditional)ATTN: Judi Weissinger PHONE NO : 49 234 97476026 OPFIKONERSTRASSE 10 SE DECISION MADE: 07‐AUG‐15BASSERSDORF CH 8303 510(k) STATEMENT DEVICE: Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test MidstreamGuangzhou Wondfo Biotech Co., Ltd.510(k) NO: K150022 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150022.pdf)(Traditional)ATTN: Ben Chen PHONE NO : 86 2032 296069 Wondfo Scientech Park, South ChinaSE DECISION MADE: 07‐AUG‐15Guangzhou CN 510641 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Implanova DENTAL EVOLUTIONS INC. 510(k) NO: K150040 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150040.pdf)(Traditional)ATTN: PARSA T ZADEH PHONE NO : 310 2732819 9100 WILSHIRE BLVD. SUITE W448 SE DECISION MADE: 27‐AUG‐15BEVERLY HILLS CA 90212 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Transcutaneous Electrical Nerve Stimulators (TENS)ANDON HEALTH CO.,LTD 510(k) NO: K150043 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150043.pdf)(Traditional)ATTN: Liu Yi PHONE NO : 86 226052 61618060 NO 3, JIN PING STREET NANKAI DISSE DECISION MADE: 14‐AUG‐15TIANJIN CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Titan
TZORA ACTIVE SYSTEMS LTD. 510(k) NO: K150086 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150086.pdf)(Traditional)ATTN: Adi Shemer PHONE NO : 972 2 9908207 SE DECISION MADE: 05‐AUG‐15Kibbutz Tzora IL 9980300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ReDs Wearable SystemSENSIBLE MEDICAL INNOVATIONS LTD. 510(k) NO: K150095(Traditional)ATTN: Inbal Ben‐Tzvi PHONE NO : 972 9865 4402 4 HAALON ST. KEFAR NETER POB 8702 SE DECISION MADE: 06‐AUG‐15NETANYA IL 4059300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Normal Saline FlushNURSE ASSIST, INC. 510(k) NO: K150143(Traditional)ATTN: Brian Cox PHONE NO : 1 817 2311300 4409 Haltom Rd SE DECISION MADE: 31‐AUG‐15Haltom City TX 76117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biogel PI Micro Indicator UndergloveMOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K150146 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150146.pdf)(Traditional)ATTN: Megan Bevill PHONE NO : 470 3750049 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 31‐AUG‐15NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANAM Test System: Military BatteryVista LifeSciences, Inc. 510(k) NO: K150154 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150154.pdf)(Traditional)ATTN: Lori White PHONE NO : 888 7338804 1PO Box 4670 SE DECISION MADE: 28‐AUG‐15Parker CO 80134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sertera Biopsy DeviceHologic, INC 510(k) NO: K150169 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150169.pdf)(Traditional)ATTN: Brenda Geary PHONE NO : 508 2638819 250 Campus Drive SE DECISION MADE: 14‐AUG‐15Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Curing LightMONITEX INDUSTRIAL CO., LTD. 510(k) NO: K150205 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150205.pdf)(Traditional)ATTN: SHU‐LUNG WANG PHONE NO : 886 2 29993869 6F, 70 SEC. 1 GUANG‐FU ROAD, SANCHSE DECISION MADE: 24‐AUG‐15NEW TAIPEI CITY TW 241‐58 510(k) STATEMENT DEVICE: STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra‐FastEB NEURO, S.P.A. 510(k) NO: K150220 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150220.pdf)(Traditional)ATTN: Christiano Pineider PHONE NO : 39 055 4565111 VIA PIETRO FANFANI 97/A SE DECISION MADE: 19‐AUG‐15FLORENCE IT 50127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring SystemInfopia Co., Ltd. 510(k) NO: K150274 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150274.pdf)(Special)ATTN: NA YUN KIM PHONE NO : 82 31460 0415 132, Anyangcheondong‐ro, Dongan‐guSE DECISION MADE: 26‐AUG‐15Anyang KR 431‐836 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDO Absorbable Punctum PlugRIVERPOINT MEDICAL 510(k) NO: K150288 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150288.pdf)(Traditional)ATTN: Edwin Anderson PHONE NO : 503 5178001 825 NE 25th Avenue SE DECISION MADE: 28‐AUG‐15Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOLINE S.p.A.CARDIOLINE S.p.A 510(k) NO: K150289(Traditional)ATTN: Emanuele Ercoli PHONE NO : 039 0463 850125 Via De Zinis, 6 SE DECISION MADE: 27‐AUG‐15CAVARENO TN 38011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP)Blood Pressure Monitor
Health & Life Co., Ltd. 510(k) NO: K150311 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150311.pdf)(Traditional)ATTN: Sarah Su PHONE NO : 886 2 82271300 12019F, No. 186, Jian Yi Road SE DECISION MADE: 18‐AUG‐15Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Electrophysiology Diagnostic CathetersSTERILMED, INC. 510(k) NO: K150357(Traditional)ATTN: Nicole Boser PHONE NO : 1 763 4883441 5010 Cheshire Pkwy Ste 2 SE DECISION MADE: 27‐AUG‐15Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Omega LIF SystemAMENDIA, INC. 510(k) NO: K150395 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150395.pdf)(Traditional)ATTN: Bruce Hooper PHONE NO : 877 7553329 1755 W. OAK PARKWAY SE DECISION MADE: 10‐AUG‐15MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUM 100ProOB TOOLS, LTD. 510(k) NO: K150398 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150398.pdf)(Traditional)ATTN: GAL BEN DAVID PHONE NO : 972 4 6040162 MIFALEY HAEMEK INDUSTRIAL ZONE P.OSE DECISION MADE: 06‐AUG‐15MIGDAL HA‐EMEK IL 2310502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorThe Binding Site Group Ltd 510(k) NO: K150412 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150412.pdf)(Traditional)ATTN: Marianne Sender PHONE NO : 44 121 4569500 8 Calthorpe Road, SE DECISION MADE: 28‐AUG‐15Edgbaston GB B15 1QT 510(k) STATEMENT DEVICE: IDODENTINE DISC, IDODENTINE BLOCKUNION DENTAL S.A. 510(k) NO: K150432 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150432.pdf)(Traditional)ATTN: JOSE LUIS RODRIGUEZ BLANCO PHONE NO : 0034 918 737630 PASEO DE LA ESTACION, 4. SE DECISION MADE: 14‐AUG‐15
TIELMES ES 28550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC 510(k) NO: K150452 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150452.pdf)(Traditional)ATTN: Richard Rush PHONE NO : 650 7669666 257 Castro Street, #216 SE DECISION MADE: 13‐AUG‐15Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medtronic Confida Brecker GuidewireMedtronic CoreValve, LLC. 510(k) NO: K150465(Traditional)ATTN: Genevieve Balutowski Dunbar PHONE NO : 1 707 5911911 3576 Unocal Place SE DECISION MADE: 03‐AUG‐15Santa Rosa CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cascadia Interbody SystemK2M, Inc. 510(k) NO: K150481(Traditional)ATTN: Nancy Giezen PHONE NO : 571 9192000 751 Miller Drive SE SE DECISION MADE: 20‐AUG‐15Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ManipulatOR PRO, ManipulatORGYNETECH PTY. LTD. 510(k) NO: K150519 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150519.pdf)(Traditional)ATTN: Brett Telford PHONE NO : 61 3 94135588 122‐124 Balmain Street SE DECISION MADE: 19‐AUG‐15Richmond AU 3121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sensititre 18‐24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4‐ 64/4ug/mL)THERMO FISHER SCIENTIFIC 510(k) NO: K150556 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150556.pdf)(Traditional)ATTN: CYNTHIA KNAPP PHONE NO : 800 8718909 3221 THERMO FISHER WAY SE DECISION MADE: 28‐AUG‐15OAKWOOD VILLAGE OH 440146 510(k) STATEMENT DEVICE: Spaulding Electrocardiograph 2100iQ
Spaulding Clinical Research, LLC 510(k) NO: K150564 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150564.pdf)(Traditional)ATTN: Andre Leak PHONE NO : 262 3063086 129525 S.Silverbrook Drive SE DECISION MADE: 12‐AUG‐15West Bend WI 53095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Respire Pink Series‐Herbst‐EFRespire Medical Holding 510(k) NO: K150572 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150572.pdf)(Traditional)ATTN: David Walton PHONE NO : 718 6437326 18 Bridge St Suite 4J SE DECISION MADE: 27‐AUG‐15Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Stryker Suture TapeStryker 510(k) NO: K150584 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150584.pdf)(Traditional)ATTN: Taylor White PHONE NO : 303 3367285 5670 Greenwood Plaza Blvd, Suite 2SE DECISION MADE: 13‐AUG‐15Greenwood Village CO 80111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reveal LINQMEDTRONIC INC. 510(k) NO: K150614(Traditional)ATTN: DIANNA L. JOHANNSON PHONE NO : 1 763 5262376 8200 CORAL SEA ST NE SE DECISION MADE: 06‐AUG‐15MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OsteoSelect PLUS Demineralized Bone Matrix PuttyBACTERIN INTERNATIONAL INC. 510(k) NO: K150621 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150621.pdf)(Traditional)ATTN: Howard L Schrayer PHONE NO : 1 406 3880480 600 Cruiser Ln SE DECISION MADE: 18‐AUG‐15BELGRADE MT 59714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mmARTHREX, INC. 510(k) NO: K150648(Traditional)ATTN: Laura Medlin PHONE NO : 239 6435553 720051370 CREEKSIDE BOULEVARD SE DECISION MADE: 20‐AUG‐15
NAPLES FL 34108‐1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitTHE BINDING SITE GROUP LTD 510(k) NO: K150658 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150658.pdf)(Traditional)ATTN: Andrea Thomas PHONE NO : 44 0121 4569500 8 CALTHORPE ROAD, SE DECISION MADE: 26‐AUG‐15BIRMINGHAM GB B15 1QT 510(k) STATEMENT DEVICE: Philips Spectral CT ApplicationsPHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K150665 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150665.pdf)(Traditional)ATTN: NONE PROVIDED PHONE NO : VEENPLUIS 4‐6 SE DECISION MADE: 07‐AUG‐15BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNFIX Evolution Secured Spacer SystemSYNTHES (USA) PRODUCTS LLC 510(k) NO: K150673 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150673.pdf)(Traditional)ATTN: EUGENE BANG PHONE NO : 508 9773966 325 Paramount Drive SE DECISION MADE: 21‐AUG‐15Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Skynector CPAP MaskSKY WISE MEDICAL INSTRUMENT (SHEN 510(k) NO: K150685 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150685.pdf)(Traditional)ATTN: Field Fu PHONE NO : NO.12 SOUTH PING XI RD XINSHENG COSE DECISION MADE: 24‐AUG‐15SHENZHEN, GUANG DONG CN 518110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOS Stent with Electrocautery Enhanced Delivery SystemBOSTON SCIENTIFIC CORP. 510(k) NO: K150692 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150692.pdf)(Traditional)ATTN: Carole Sykes PHONE NO : 650 9619900 453 Ravendale Drive, Suite H SE DECISION MADE: 05‐AUG‐15Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ModpodHOLLYWOG, LLC 510(k) NO: K150695 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150695.pdf)(Traditional)ATTN: MICHAEL TREAS PHONE NO : 1 423 3057778 1082830 AMMICOLA HIGHWAY SE DECISION MADE: 13‐AUG‐15CHATTANOOGA TN 37377 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)KURARAY NORITAKE DENTAL INC. 510(k) NO: K150703 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150703.pdf)(Traditional)ATTN: MICHIO TAKIGAWA PHONE NO : 81 3 67011706 OTE CENTER BLDG. 7F, 1‐1‐3, OTEMACSE DECISION MADE: 13‐AUG‐15CHIYODA‐KU JP 100‐0004 510(k) STATEMENT DEVICE: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try‐in Paste (Universal (A2)), Try‐in Paste (Clear), Try‐in Paste (Brown (A4)), Try‐in Paste (White), Try‐in Paste (Opaque), Tooth Primer KURARAY NORITAKE DENTAL, INC. 510(k) NO: K150704 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150704.pdf)(Traditional)ATTN: MICHIO TAKIGAWA PHONE NO : 81 3 67011706 Ote Center Bldg. 7F, 1‐1‐3, OtemacSE DECISION MADE: 21‐AUG‐15Chiyoda ku JP 1000004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMEDTRONIC XOMED, INC. 510(k) NO: K150728(Traditional)ATTN: Gabriela Anchonda PHONE NO : 904 2797550 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 14‐AUG‐15JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Force TriVerse Electrosugical Device, Holster, 10‐foot, Force TriVerse Electrosurgical Device, Holster, 15‐footCOVIDIEN 510(k) NO: K150735 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150735.pdf)(Traditional)ATTN: NANCY SAUER PHONE NO : 303 5816791 5920 LONGBOW DRIVE SE DECISION MADE: 04‐AUG‐15BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc510(k) NO: K150745 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150745.pdf)(Traditional)ATTN: Kimberly Mangum PHONE NO : 610 4481787 51 Valley Stream Parkway SE DECISION MADE: 11‐AUG‐15Malvem PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.CT Dual EnergySIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K150757 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150757.pdf)(Traditional)ATTN: Kimberly Mangum PHONE NO : 610 4484912 51 VALLEY STREAM PARKWAY SE DECISION MADE: 11‐AUG‐15MALVEN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDOSEGUANGZHOU RAYDOSE SOFTWARE TECHNOL510(k) NO: K150767 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150767.pdf)(Traditional)ATTN: DENNIS DONG PHONE NO : 86 20 87764746 8020NO.850 EAST DONGFENG ROAD, GUANGZHSE DECISION MADE: 17‐AUG‐15GUANGZHOU CN 510060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RxG Distraction SystemKLS MARTIN L.P. 510(k) NO: K150771 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150771.pdf)(Traditional)ATTN: JENNIFER DAMATO PHONE NO : 1 800 6251557 11201 SAINT JOHNS INDUSTRIAL PKWY.SE DECISION MADE: 27‐AUG‐15JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rezum SystemNxThera, Inc. 510(k) NO: K150786(Traditional)ATTN: J. Robert Paulson, JD PHONE NO : 1 763 5150404 7351 Kirkwood Lane N. SUITE 138 SE DECISION MADE: 27‐AUG‐15Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vyntus / SentrySuite Product LineCareFusion Germany 234 GmbH 510(k) NO: K150810 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150810.pdf)(Traditional)
ATTN: Elmar Niedermeyer PHONE NO : 49 931 4972361 Leibnizstrasse 7 SE DECISION MADE: 14‐AUG‐15Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Straumann Screw‐Retained AbutmentSTRAUMANN USA, LLC 510(k) NO: K150814 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150814.pdf)(Traditional)ATTN: Manuela Ventur PHONE NO : 1 978 7472500 60 MINUTEMAN ROAD SE DECISION MADE: 10‐AUG‐15ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TriglyceridesRandox Laboratories Limited 510(k) NO: K150819 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150819.pdf)(Traditional)ATTN: Pauline Armstrong PHONE NO : 44 2894 422413 227555 Diamond Road SE DECISION MADE: 06‐AUG‐15Crumlin GB BT29 4Qy 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDLENi Intra‐Oral SensorEDLEN IMAGING LLC 510(k) NO: K150823 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150823.pdf)(Abbreviated)ATTN: Nick Radachi PHONE NO : 480 6598430 16441 NORTH 91ST STREET SUITE 102 SE DECISION MADE: 26‐AUG‐15SCOTTSDALE AZ 85250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Foundation Interbody DevicesCORELINK LLC 510(k) NO: K150847 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150847.pdf)(Traditional)ATTN: Sharon Gregory PHONE NO : 1 888 3497808 7606 FORSYTH BLVD SE DECISION MADE: 13‐AUG‐15CLAYTON MO 63105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Banana GoldHANKOOK LATEX GONGUP CO., LTD. 510(k) NO: K150857 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150857.pdf)(Traditional)ATTN: KWON DUKEE PHONE NO : 82 33 2501100 61, SAKJU‐RO 145BEON‐GIL SE DECISION MADE: 14‐AUG‐15CHUNCHEON‐SI KR 200‐060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metacross RX PTA Balloon Dilitation CatheterKaneka Corporation 510(k) NO: K150865 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150865.pdf)(Traditional)ATTN: Toshihiko Motomine PHONE NO : 81 35574 8023 1‐12‐32, Akasaka, Minato‐ku SE DECISION MADE: 03‐AUG‐15Tokyo JP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ForeFoot STP SystemTORNIER, INC. 510(k) NO: K150871 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150871.pdf)(Traditional)ATTN: BRIAN HOCKETT PHONE NO : 330 8699562 1065 MEDINA RD, SUITE 500 SE DECISION MADE: 04‐AUG‐15MEDINA OH 44256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIA 21 MicrocatheterSEQUENT MEDICAL, INC 510(k) NO: K150894 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150894.pdf)(Traditional)ATTN: Bethany Barrett PHONE NO : 949 8309600 11A COLUMBIA SE DECISION MADE: 28‐AUG‐15ALISO VIEJO CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vitality Spinal Fixation SystemZIMMER SPINE, INC. 510(k) NO: K150896 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150896.pdf)(Traditional)ATTN: DONNA M. SEMLAK PHONE NO : 1 952 8575643 7375 BUSH LAKE RD. SE DECISION MADE: 31‐AUG‐15MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMATERIALISE N.V. 510(k) NO: K150928 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150928.pdf)(Traditional)ATTN: Laurel Berzanskis PHONE NO : 32 1674 4537 TECHNOLOGIELAAN 15 SE DECISION MADE: 10‐AUG‐15LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CareView 1500Cw X‐ray Flat Panel Detectors
CARERAY DIGITAL MEDICAL SYSTEM CO.510(k) NO: K150929 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150929.pdf)(Traditional)ATTN: YULING DING PHONE NO : 86 512 86860288 A2‐201/B3‐501, BIOBAY, 218 XINGHU SE DECISION MADE: 04‐AUG‐15SUNZHOU CN 215123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFOCUS DIAGNOSTICS 510(k) NO: K150962 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150962.pdf)(Traditional)ATTN: SHARON YOUNG PHONE NO : 562 2406680 11331 VALLEY VIEW STREET SE DECISION MADE: 28‐AUG‐15CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Zekang Self‐adhesive ElectrodeJiangsu Zekang Medical Technology 510(k) NO: K150971 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150971.pdf)(Traditional)ATTN: Doris Dong PHONE NO : 86 510 85388899 Building 22, Wuxi Zhongguancun SofSE DECISION MADE: 25‐AUG‐15Wuxi CN 214135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy DrugsTERANG NUSA SND BHD 510(k) NO: K150973 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150973.pdf)(Traditional)ATTN: ROBERT HILL PHONE NO : 0060 977 47171 1 JALAN 8, PENGKALAN CHEPA 2 IND. SE DECISION MADE: 04‐AUG‐15KOTA BHARU MY 16100 510(k) STATEMENT DEVICE: Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMEDDEV CORPORATION 510(k) NO: K150986 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150986.pdf)(Traditional)ATTN: PATRICK GREY PHONE NO : 408 7309702 730 NORTH PASTORIA AVE SE DECISION MADE: 17‐AUG‐15SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O‐Arm O2 Imaging SystemMEDTRONIC INC. 510(k) NO: K151000 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151000.pdf)(Traditional)
ATTN: RISHI SINHA PHONE NO : 269 9034373 300 FOSTER STREET SE DECISION MADE: 06‐AUG‐15LITTLETON MA 01460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EarlySense Central Display Station (CDS)EARLYSENSE LTD. 510(k) NO: K151006(Traditional)ATTN: DALIA ARGAMAN PHONE NO : 972 3 7522330 12 TZVI ST SE DECISION MADE: 31‐AUG‐15RAMAT‐GAN IL 5250429 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINK® MEGASYSTEM‐C®Waldemar Link GmbH & Co. KG 510(k) NO: K151008 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151008.pdf)(Traditional)ATTN: Helmut D Link PHONE NO : 49 40 539950 Barkhausenweg 10 SE DECISION MADE: 26‐AUG‐15Hamburg DE 22339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nexus SutureBAYLIS MEDICAL COMPANY INC. 510(k) NO: K151009 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151009.pdf)(Traditional)ATTN: Meghal Khakhar PHONE NO : 905 6024875 2645 MATHESON BLVD. EAST SE DECISION MADE: 18‐AUG‐15MISSISSAUGA CA L4W 5S4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPACT PIEZO LEDMECTRON SPA 510(k) NO: K151023 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151023.pdf)(Traditional)ATTN: FRANCO ZUNINO PHONE NO : 39 0185 35361 VIA LORETO 15 SE DECISION MADE: 05‐AUG‐15CARASCO IT 16042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aesculap T‐Space PEEK and XP Spinal SystemAESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K151056 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151056.pdf)(Traditional)ATTN: LISA M. BOYLE PHONE NO : 1 610 9849274 3773 CORPORATE PWKY. SE DECISION MADE: 13‐AUG‐15CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WASTON Metallic Bone Plate and Screw SystemsCHANGZHOU WASTON MEDICAL APPLIANCE510(k) NO: K151057 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151057.pdf)(Traditional)ATTN: Jack Lu PHONE NO : 86 519 86522226 9 Xihu Road, Wujin Hi‐tech IndustrSE DECISION MADE: 10‐AUG‐15Changzhou CN 213168 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cornea ColdEUROBIO 510(k) NO: K151061 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151061.pdf)(Traditional)ATTN: Marie‐Claude Amoureux PHONE NO : 33 4 91269750 7, AVENUE DE SCANDINAVIE SE DECISION MADE: 06‐AUG‐15LES ULIS FR F‐91953 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solitaire‐C Cervical Spacer System, C‐Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion SystemBIOMET SPINE 510(k) NO: K151064 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151064.pdf)(Traditional)ATTN: Alexandra Beck PHONE NO : 303 5018397 310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 12‐AUG‐15BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS 8100SC, CS8100SC AccessTROPHY 510(k) NO: K151087 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151087.pdf)(Traditional)ATTN: MARIE‐PIERRE LABAT‐CAMY PHONE NO : 33 1 64808500 4 RUE F. PELLOUTIER SE DECISION MADE: 21‐AUG‐15CROISSY‐BEAUBOURG FR 77435 510(k) STATEMENT DEVICE: DMRC Bulk FillDANVILLE MATERIALS, LLC 510(k) NO: K151088 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151088.pdf)(Traditional)ATTN: DONG HUA PHONE NO : 925 9730710 3420 FOSTORIA WAY SUITE A‐200 SE DECISION MADE: 28‐AUG‐15SAN RAMON CA 94583 510(k) STATEMENT DEVICE: Laparoscope Lens Shield Device
Medeon Biodesign, Inc 510(k) NO: K151117(Traditional)ATTN: Greta Chang PHONE NO : 886 2 28816686 7F, 116 Hougang St SE DECISION MADE: 20‐AUG‐15Taipei TW 11170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSTONE Spinal System, CLYDESDALE Spinal SystemMEDTRONIC SOFAMOR DANEK USA, INC 510(k) NO: K151128 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151128.pdf)(Traditional)ATTN: LEE GRANT PHONE NO : 1 901 3963133 1800 PYRAMID PLACE SE DECISION MADE: 06‐AUG‐15MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd 510(k) NO: K151140 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151140.pdf)(Special)ATTN: Yerim An PHONE NO : 82 26717 1985 #201, 202 16‐25, Dongbaekjungang‐rSE DECISION MADE: 18‐AUG‐15Giheung‐gu, Yongin‐si KR 446‐916 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K151142 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151142.pdf)(Traditional)ATTN: BETINA KISTNER PHONE NO : 49 7231 3705279 Lindenstr.2 SE DECISION MADE: 13‐AUG‐15Pforzheim DE D‐75175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pirouette 018ARRAVASC LIMITED 510(k) NO: K151153 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151153.pdf)(Traditional)ATTN: MAIREAD MCCAFFREY PHONE NO : 353 91 758939 2 BALLYBRIT BUSINESS PARK SE DECISION MADE: 20‐AUG‐15GALWAY IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/BridgesSTRAUMANN USA, LLC 510(k) NO: K151157 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151157.pdf)(Traditional)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 1 978 7472575 60 MINUTEMAN ROAD SE DECISION MADE: 05‐AUG‐15ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Assure Prism multi Blood Glucose Monitoring Systemi‐Sens, Inc. 510(k) NO: K151164 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151164.pdf)(Special)ATTN: JOON HO JUNG PHONE NO : 82 2 9166191 43, BANPO‐DAERO 28‐GIL, SEOCHO‐GU SE DECISION MADE: 07‐AUG‐15SEOUL KR 137‐873 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Instru‐Safe Instrument Protection SystemSummit Medical Inc. 510(k) NO: K151166 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151166.pdf)(Traditional)ATTN: Nicole Dove PHONE NO : 651 7893939 815 Northwest Parkway, Suite 100 SE DECISION MADE: 18‐AUG‐15St. Paul MN 55121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT ContainMEDTRONIC SOFAMOR DANEK USA, INC 510(k) NO: K151172 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151172.pdf)(Traditional)ATTN: Gregory K Maschek PHONE NO : 901 3469738 1800 PYRAMID PLACE SE DECISION MADE: 14‐AUG‐15MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ScandiDos Delta4 Phantom+SCANDIDOS AB 510(k) NO: K151180 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151180.pdf)(Traditional)ATTN: THOMAS MATZEN PHONE NO : 46 18 4723030 DAG HAMMARSKJOLDS VAG 52A SE DECISION MADE: 19‐AUG‐15UPPSALA SE SE‐75237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceETHICON, INC. 510(k) NO: K151200 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151200.pdf)(Traditional)ATTN: DONNA MARSHALL PHONE NO : 908 5413990 ROUTE 22 WEST P.O. BOX 151 SE DECISION MADE: 13‐AUG‐15
SOMERVILLE NJ 08876‐0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fingertip Pulse Oximeter BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K151206 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151206.pdf)(Traditional)ATTN: LEI CHEN PHONE NO : 86 10 88798300 6020NO. 9 SHUANGYUAN ROAD, BADACHU HI‐SE DECISION MADE: 28‐AUG‐15BEIJING CN 100041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCP Drug Test Mini CupsUCP BIOSCIENCES, INC 510(k) NO: K151213 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151213.pdf)(Special)ATTN: NANCY CHEN PHONE NO : 408 3920064 1445 KOLL CIRCLE, STE 111 SE DECISION MADE: 21‐AUG‐15SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Everest Spinal SystemK2M, Inc 510(k) NO: K151216 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151216.pdf)(Traditional)ATTN: Nancy Giezen PHONE NO : 571 9182000 751 Miller Drive SE SE DECISION MADE: 10‐AUG‐15Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBEIJING POLYCON MEDICAL ENGINEERIN510(k) NO: K151219 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151219.pdf)(Abbreviated)ATTN: XIANGCHEN LIU PHONE NO : 8610 8811 0881 HAI DIAN QU BUILDING 9 FU WAI LIANSE DECISION MADE: 04‐AUG‐15BEIJING CN 100142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIKINI Diode Laser SystemILOODA CO., LTD 510(k) NO: K151232 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151232.pdf)(Traditional)ATTN: Suhee Nam PHONE NO : 82 31278 4661 #801‐805, Venture Valley 40, OmokcSE DECISION MADE: 06‐AUG‐15Gwonseon‐gu, Suwon‐si KP 510(k) STATEMENT
DEVICE: Medline Foot Plates and ScrewsMEDLINE INDUSTRIES, INC. 510(k) NO: K151235 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151235.pdf)(Traditional)ATTN: Jennifer Mason PHONE NO : 847 6433652 ONE MEDLINE PLACE SE DECISION MADE: 06‐AUG‐15MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Synchro‐Medical TIGER TRACK Screw SystemSynchro Medical 510(k) NO: K151241 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151241.pdf)(Traditional)ATTN: Danilo Campani PHONE NO : 330 3 89237564 21 rue des Merisiers SE DECISION MADE: 07‐AUG‐15Wettolsheim les Erlen FR FR‐68920510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy 510(k) NO: K151243 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151243.pdf)(Traditional)ATTN: GOLNAZ MOEINI PHONE NO : 408 7542000 5900 Optical Ct SE DECISION MADE: 20‐AUG‐15SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC Straumann Screw Retained AbutmentsSTRAUMANN USA, LLC 510(k) NO: K151247 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151247.pdf)(Traditional)ATTN: CHRISTOPHER KLACZYK PHONE NO : 1 978 7472575 60 MINUTEMAN ROAD SE DECISION MADE: 10‐AUG‐15ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex BioSync® Bone WedgeArthex, Inc 510(k) NO: K151256 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151256.pdf)(Traditional)ATTN: Laura Medlin PHONE NO : 239 6435553 720051370 Creekside Boulevard SE DECISION MADE: 12‐AUG‐15Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Restoration Anatomic ShellSTRYKER ORTHOPAEDICS 510(k) NO: K151264
(http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151264.pdf)(Traditional)ATTN: Allison M Ling PHONE NO : 201 8516520 325 Corporate Drive SE DECISION MADE: 10‐AUG‐15Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Airlock® osteosynthesis plate systemNOVASTEP 510(k) NO: K151277 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151277.pdf)(Traditional)ATTN: GILLES AUDIC PHONE NO : 33 299 338650 Espace performance Alphasis ‐ BatiSE DECISION MADE: 13‐AUG‐15Saint Gregoire FR 35769 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIS Integrated System Mobile WorkstationLIGHTLAB IMAGING, INC. 510(k) NO: K151286(Traditional)ATTN: Padmini Suravaram PHONE NO : 978 5773473 4 ROBBINS ROAD SE DECISION MADE: 05‐AUG‐15WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)NONIN MEDICAL INC. 510(k) NO: K151305 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151305.pdf)(Traditional)ATTN: LAURA J. LIND PHONE NO : 763 5539968 267413700 1ST AVENUE NORTH SE DECISION MADE: 27‐AUG‐15PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wartie Advanced Wart Remover or other proprietary nameYOUMEDICAL CORP BV 510(k) NO: K151309 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151309.pdf)(Traditional)ATTN: FRANCESCA MAPPA PHONE NO : 0031 20 6798529 RIJNSBURGSTRAAT 9‐11 SE DECISION MADE: 14‐AUG‐15AMSTERDAM NL 1059 AT 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 Hip Stem, Ti Porous Coated, MatrixUnited Orthopedic Corporation 510(k) NO: K151316 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151316.pdf)(Traditional)ATTN: Karen Ho PHONE NO : 886 3 5773351 2212No 57, Park Ave 2, Science Park SE DECISION MADE: 13‐AUG‐15
Hsinchu TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Eko Electronic Stethoscope SystemEko Devices, Inc. 510(k) NO: K151319(Traditional)ATTN: Connor Landgraf PHONE NO : 1 844 3563384 2600 10th St, Suite 260 SE DECISION MADE: 28‐AUG‐15Berkeley CA 94710 510(k) STATEMENT DEVICE: Bovie J‐Plasma Handpiece BOVIE MEDICAL CORPORATION 510(k) NO: K151325 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151325.pdf)(Traditional)ATTN: Brian Kunst PHONE NO : 727 8038617 5115 ULMERTON ROAD SE DECISION MADE: 04‐AUG‐15CLEARWATER FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nexus Universal, Nexus Universal ChromaSYBRON DENTAL SPECIALTIES 510(k) NO: K151332 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151332.pdf)(Abbreviated)ATTN: COURTNEY CLARK PHONE NO : 714 5167426 1717 W. COLLINS AVENUE SE DECISION MADE: 17‐AUG‐15ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LightStim for Pain LED BeltLED INTELLECTUAL PROPERTIES, LLC 510(k) NO: K151333(Traditional)ATTN: Steve Marchese PHONE NO : 949 5024088 16552 VON KARMAN AVE. SE DECISION MADE: 21‐AUG‐15IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Turbo High‐Flow Non‐coring NeedleNORFOLK MEDICAL 510(k) NO: K151341 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151341.pdf)(Traditional)ATTN: NATAN PHEIL PHONE NO : 847 6747075 7350 N. RIDGEWAY AVENUE SE DECISION MADE: 20‐AUG‐15SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
HARTALEGA NGC SDN BHD 510(k) NO: K151343 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151343.pdf)(Traditional)ATTN: KUAN MUN LEONG PHONE NO : 603 62771733 NO. 1, PERSIARAN TANJUNG, LOT PT43SE DECISION MADE: 24‐AUG‐15SEPANG MY 65000 510(k) STATEMENT DEVICE: BioGuard Air/Water Valve, BioGuard Suction ValveUNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K151345 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151345.pdf)(Traditional)ATTN: CARROLL L. MARTIN PHONE NO : 1 440 3586259 5976 HEISLEY ROAD SE DECISION MADE: 25‐AUG‐15MENTOR OH 44060 510(k) STATEMENT DEVICE: Frontier Medical Devices Posterior Cable Screw SystemFRONTIER MEDICAL DEVICES, INC. 510(k) NO: K151346 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151346.pdf)(Traditional)ATTN: BETHANY BYMAN PHONE NO : 906 2321200 512 FOURTH STREET SE DECISION MADE: 20‐AUG‐15GWINN MI 49841 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)HEALGEN SCIENTIFIC LLC 510(k) NO: K151348 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151348.pdf)(Traditional)ATTN: JIANQIU FANG PHONE NO : 713 7338088 5213 MAPLE ST SE DECISION MADE: 18‐AUG‐15BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Advanced Perfusion System 1Terumo Cardiovascular Systems Corp510(k) NO: K151349(Traditional)ATTN: John Chesney PHONE NO : 734 7416410 6200 Jackson Road SE DECISION MADE: 27‐AUG‐15Ann Arbor MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.MR Neurology, syngo.MR OncologySIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K151353 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151353.pdf)(Traditional)
ATTN: CORDELL L. FIELDS PHONE NO : 610 2198518 51 VALLEY STREAM PARKWAY SE DECISION MADE: 07‐AUG‐15MAVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: .decimal p.d.DECIMAL, LLC 510(k) NO: K151369 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151369.pdf)(Traditional)ATTN: KEVIN ERHART PHONE NO : 407 3303300 121 CENTRAL PARK PLACE SE DECISION MADE: 07‐AUG‐15SANFORD FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corporate Dental Imaging (CDI) ApplicationU.S. ARMY DENTAL COMMAND (DENCOM) 510(k) NO: K151371 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151371.pdf)(Traditional)ATTN: WILLIAM K. PORTER PHONE NO : 210 8082748 4270 GORGES CIRCLE, SUITS 101, B10SE DECISION MADE: 19‐AUG‐15FORT SAM HOUSTON TX 78234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Low Dose CT Lung Cancer Screening Option for Qualified GE SystemsGE Medical Systems, LLC 510(k) NO: K151372 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151372.pdf)((Traditional)ATTN: John Jaeckle PHONE NO : 262 4249547 3000 North Grandview Blvd SE DECISION MADE: 14‐AUG‐15Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Corvocet Coaxial IntroducerMerit Medical Systems, Inc. 510(k) NO: K151373 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151373.pdf)(Traditional)ATTN: Ileana Garcia PHONE NO : 801 2084187 1600 West Merit Parkway SE DECISION MADE: 07‐AUG‐15South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive MLX‐Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF SystemNuVasive, Incorporated 510(k) NO: K151374 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151374.pdf)(Traditional)ATTN: Olga Lewis PHONE NO : 858 3205257 7475 Lusk Boulevard SE DECISION MADE: 06‐AUG‐15
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Conventus PRS SystemConventus Orthopaedics, Inc 510(k) NO: K151379 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151379.pdf)(Traditional)ATTN: Kent R Lind PHONE NO : 763 5155003 10200 73rd Avenue North, Suite 122SE DECISION MADE: 13‐AUG‐15Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.via RT Image SuiteSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K151380 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151380.pdf)(Traditional)ATTN: EVE DAVIS PHONE NO : 610 2197133 51 VALLEY STREAM PARKWAY SE DECISION MADE: 13‐AUG‐15MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECON system NORMED MEDIZIN‐TECHNIK GMBH 510(k) NO: K151407 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151407.pdf)(Traditional)ATTN: ARNE BRIEST PHONE NO : 49 7461 93430 ULRICHSTRASSE 7 SE DECISION MADE: 12‐AUG‐15TUTTLINGEN DE D‐78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Selectra Catheters and Selectra Accessory KitBIOTRONIK, INC. 510(k) NO: K151409(Special)ATTN: JON BRUMBAUGH PHONE NO : 888 3450374 6024 JEAN ROAD SE DECISION MADE: 07‐AUG‐15LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reform Pedicle Screw SystemPrecision Spine, Inc. 510(k) NO: K151422 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151422.pdf)(Traditional)ATTN: Michael C. Dawson PHONE NO : 601 4204244 1282050 Executive Drive SE DECISION MADE: 21‐AUG‐15Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
ATRIUM MEDICAL CORPORATION 510(k) NO: K151437 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151437.pdf)(Traditional)ATTN: TIMOTHY J. TALCOTT PHONE NO : 603 8801433 53425 WENTWORTH DRIVE SE DECISION MADE: 27‐AUG‐15HUDSON NH 03051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsZIMMER, INC. 510(k) NO: K151448 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151448.pdf)(Traditional)ATTN: KEITH PROCTOR PHONE NO : 1 574 3724781 P.O. BOX 708 SE DECISION MADE: 13‐AUG‐15WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Integra Total Ankle Replacement SystemAscension Orthopedics 510(k) NO: K151459 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151459.pdf)(Traditional)ATTN: Frederic Testa PHONE NO : 609 9363630 8700 Cameron Road, Suite 100 SE DECISION MADE: 31‐AUG‐15Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SI‐TECHNOLOGY® SI‐DESIS® SCREWSSI‐TECHNOLOGY, LLC 510(k) NO: K151462 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151462.pdf)(Traditional)ATTN: CHRIS DONNER PHONE NO : 970 4221212 320 EAST VINE DRIVE, SUITE 217 SE DECISION MADE: 12‐AUG‐15FORT COLLINS CO 80524 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHANSEN MEDICAL, INC. 510(k) NO: K151463 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151463.pdf)(Special)ATTN: Elisa Aldridge PHONE NO : 650 4042784 800 E. MIDDLEFIELD ROAD SE DECISION MADE: 18‐AUG‐15MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Capillus82Capillus, LLC 510(k) NO: K151516 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151516.pdf)(Special)ATTN: PATRICIA SCHNOOR PHONE NO : 786 8881874
1715 NW 82ND AVENUE SE DECISION MADE: 21‐AUG‐15MIAMI FL 33126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Respiratory Gating for ScannersVARIAN MEDICAL SYSTEMS, INC 510(k) NO: K151533 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151533.pdf)(Traditional)ATTN: PETER J. CORONADO PHONE NO : 650 4246320 3100 HANSEN WAY SE DECISION MADE: 13‐AUG‐15PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Leksell Gamma Knife IconELEKTA INSTRUMENT AB 510(k) NO: K151561 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151561.pdf)(Traditional)ATTN: MATILDA FORSBERG PHONE NO : 011 468 58725400 KUNGSTENSGATAN 18 SE DECISION MADE: 04‐AUG‐15STOCKHOLM SE 10393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Digital Automatic Wrist Blood Pressure Monitor MD3900GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K151583(Traditional)ATTN: PATRICK CHOW PHONE NO : 00852 2851 6789 BLOCK 7, ZHU KENG INDUSTRIAL ZONE,SE DECISION MADE: 07‐AUG‐15SHENZHEN CN 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. 510(k) NO: K151586 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151586.pdf)(Traditional)ATTN: WEN‐HAN CHEN PHONE NO : 886 4 25658384 1563F‐1, NO. 6, JHONGKE ROAD, DAYA DISE DECISION MADE: 10‐AUG‐15TAICHUNG CITY TW 42881 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Digital Automatic Wrist Blood Pressure Monitor MD3200GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K151587(Traditional)ATTN: Patrick Chow PHONE NO : 00852 2851 6789 Block 7, Zhu Keng Industrial Zone,SE DECISION MADE: 07‐AUG‐15SHENZHEN CN 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Angel pedicle screw spinal system
JIANGSU ANGEL MEDICAL INSTRUMENT C510(k) NO: K151591 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151591.pdf)(Traditional)ATTN: SHENG XIANG MA PHONE NO : 86 0512 58560125 NO. 168 JINYANGHE ROAD, JINFENG TOSE DECISION MADE: 18‐AUG‐15ZHANGJIAGANG CITY CN 215625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VesselNavigator Rel. 1.0PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K151598 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151598.pdf)(Abbreviated)ATTN: LISELOTTE KORNMANN PHONE NO : 31 6 11621238 VEENPLUIS 4‐6 SE DECISION MADE: 17‐AUG‐15BEST NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Penumbra System 110 Aspiration TubingPenumbra, Inc. 510(k) NO: K151623 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151623.pdf)(Special)ATTN: Michaela Mahl PHONE NO : 510 7483288 One Penumbra Place SE DECISION MADE: 06‐AUG‐15Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Heagen Multi‐Drug Urine Test Cup, Healgen Multi‐Drug Urine Test Dip CardHEALGEN SCIENTIFIC LLC 510(k) NO: K151642 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151642.pdf)(Special)ATTN: JIANQIU FANG PHONE NO : 713 7338088 5213 MAPLE ST SE DECISION MADE: 13‐AUG‐15BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8ch Foot Ankle CoilSHENZHEN RFTECH CO., LTD. 510(k) NO: K151653 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151653.pdf)(Traditional)ATTN: KE XI PHONE NO : 086 755 26641989 2‐F, BLDG 4, JUHUI INDUSTRIAL PARKSE DECISION MADE: 07‐AUG‐15SHENZHEN CN 51832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Shielded Applicator Set, Cervical StopVARIAN MEDICAL SYSTEMS, INC 510(k) NO: K151657 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151657.pdf)(Traditional)ATTN: PETER J. CORONADO PHONE NO : 650 4246230
3100 HANSEN WAY SE DECISION MADE: 07‐AUG‐15PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS80A Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD. 510(k) NO: K151663 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151663.pdf)(Third Party ‐ Traditional)ATTN: KYEONG‐MI PAK PHONE NO : 82 2 21941373 42, TEHERAN‐RO 108‐GIL SE DECISION MADE: 12‐AUG‐15GANGNAM‐GU KR 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QuantorView3DISC AMERICAS 510(k) NO: K151687 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151687.pdf)(Traditional)ATTN: SIGRID SMITT‐JEPPESEN PHONE NO : 571 2272382 22560 GLENN DR STE 116 SE DECISION MADE: 03‐AUG‐15STERLING VA 20164 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reusable Full Silicone CoverLAERDAL MEDICAL AS 510(k) NO: K151702 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151702.pdf)(Special)ATTN: MARI KAADA PHONE NO : 47 51 511700 TANKE SVILANDSGATE 30 SE DECISION MADE: 13‐AUG‐15STAVANGER NO 4007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex Fracture PlatesARTHREX, INC. 510(k) NO: K151732 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151732.pdf)(Special)ATTN: COURTNEY SMITH PHONE NO : 239 6435553 717201370 CREEKSIDE BOULEVARD SE DECISION MADE: 28‐AUG‐15NAPLES FL 34108‐1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAZZ SystemImplanet, S.A. 510(k) NO: K151740 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151740.pdf)(Traditional)ATTN: Regis Le Couedic PHONE NO : 33 557 995555 Technopole Bordeaux Montesquieu AlSE DECISION MADE: 27‐AUG‐15Martillac FR 33650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HA Minuteman G3 MIS Fusion PlateSPINAL SIMPLICITY LLC 510(k) NO: K151741 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151741.pdf)(Traditional)ATTN: JULIE MCKEE PHONE NO : 913 4514414 10995 QUIVIRA ROAD SE DECISION MADE: 20‐AUG‐15OVERLAND PARK KS 66210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 16 ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC 510(k) NO: K151753 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151753.pdf)(Traditional)ATTN: Kathleen Aras PHONE NO : 440 4842964 700 Beta Drive Suite 100 SE DECISION MADE: 27‐AUG‐15Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERISPINE LC CAGESAFE ORTHOPAEDICS 510(k) NO: K151756 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151756.pdf)(Traditional)ATTN: Pierre Dumouchel PHONE NO : 330 13421 5000 Parc des Bellevues Allee R. LuxembSE DECISION MADE: 21‐AUG‐15Eragny Sur Oise FR 95610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Menicon Saline Rinse Solution MENICON CO.,LTD. 510(k) NO: K151768 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151768.pdf)(Traditional)ATTN: TOHRU KAWAGUCHI PHONE NO : 81 52 9351676 21‐19, AOI 3‐CHOME, NAKA‐KU SE DECISION MADE: 28‐AUG‐15NAGOYA JP 460‐0006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Central Venous Pressure SystemMespere LifeSciences Inc. 510(k) NO: K151776 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151776.pdf)(Special)ATTN: Helen Tan PHONE NO : 1 519 8847575 01180 Frobisher Dr, Unit 1C SE DECISION MADE: 12‐AUG‐15Waterloo, ON CA N2V2A2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nuocande Plastic Manual Wheelchair Model NKD L07NINGBO LECOUNT MEDICAL TECHNOLOGY 510(k) NO: K151797
(http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151797.pdf)(Traditional)ATTN: CHARLES SHEN PHONE NO : 086 574 88060005 57 LONGFEI ROAD, YUNLONG INDUSTRY SE DECISION MADE: 25‐AUG‐15NINGBO CN 315135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arc Endocuff Vision BODDINGTONS PLASTICS LTD 510(k) NO: K151801 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151801.pdf)(Special)ATTN: PAUL BLACKMORE PHONE NO : 0044 1622 833700 WHEELBARROW PARK ESTATE PATTENDEN SE DECISION MADE: 13‐AUG‐15TONBRIDGE GB TN12 9QL 510(k) STATEMENT DEVICE: Resolution ClipBOSTON SCIENTIFIC CORPORATION 510(k) NO: K151802 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151802.pdf)(Traditional)ATTN: ELENA NIEVES PHONE NO : 508 6834347 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 06‐AUG‐15MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. 510(k) NO: K151818 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151818.pdf)(Special)ATTN: Diane Brinza PHONE NO : 952 6989959 5600 Rowland Road, Suite 200 SE DECISION MADE: 05‐AUG‐15Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS 3D ImagingTROPHY 510(k) NO: K151837 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151837.pdf)(Traditional)ATTN: MARIE‐PIERRE LABAT‐CAMY PHONE NO : 33 1 64808500 4 RUE F. PELLOUTIER SE DECISION MADE: 19‐AUG‐15CROISSY‐BEAUBOURG FR 77435 510(k) STATEMENT DEVICE: McKesson CardiologyMCKESSON ISRAEL LTD. 510(k) NO: K151850 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151850.pdf)(Traditional)ATTN: GILBERT WONG PHONE NO : 972 3 7698000 HAROKMIM 26 SE DECISION MADE: 11‐AUG‐15
HOLON IL 5885849 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL80 FLEX CO‐OX with AQURE connectivitySENDX MEDICAL INC. 510(k) NO: K151856 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151856.pdf)(Special)ATTN: Vibeke Agerlin PHONE NO : 760 9306300 1945 PALOMAR OAKS WAY SE DECISION MADE: 06‐AUG‐15CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Synapse CardiovascularFUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K151859(Traditional)ATTN: JYH‐SHYAN LIN PHONE NO : 301 2511092 419 WEST AVENUE SE DECISION MADE: 12‐AUG‐15STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Precision Spine Interspinous Plate SystemPRECISION SPINE, INC. 510(k) NO: K151863 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151863.pdf)(Special)ATTN: MICHAEL C. DAWSON PHONE NO : 973 4557150 5 SYLVAN WAY, SUITE 220 SE DECISION MADE: 07‐AUG‐15PARSIPPANY NJ 07930 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STA R MAXDIAGNOSTICA STAGO S.A.S. 510(k) NO: K151867 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151867.pdf)(Special)ATTN: ARNAUD COLLIN PHONE NO : 033 146 854880 125 AVENUE LOUIS ROCHE SE DECISION MADE: 07‐AUG‐15GENNEVILLIERS FR 92230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MicroTract Access SystemARSTASIS, INC. 510(k) NO: K151877(Special)ATTN: Debra Cogan PHONE NO : 408 5150820 6500 KAISER DRIVE SUITE 120 SE DECISION MADE: 07‐AUG‐15FREMONT CA 94555 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VariAx 2 One‐Third Tubular Plating SystemSTRYKER GMBH 510(k) NO: K151879
(http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151879.pdf)(Special)ATTN: HEIKE GUSTKE PHONE NO : 49 4348 702637 PROF. KUENTSCHER STR. 1‐5 SE DECISION MADE: 06‐AUG‐15SCHOENKIRCHEN DE D‐24232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Wingman Crossing CatheterREFLOW MEDICAL 510(k) NO: K151880 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151880.pdf)(Special)ATTN: REBECCA K PINE PHONE NO : 760 8095178 1003 CALLE SOMBRA SE DECISION MADE: 07‐AUG‐15SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MultiFIX® P Knotless Fixation DeviceArthroCare Corporation 510(k) NO: K151897 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151897.pdf)(Special)ATTN: Laura Kasperowicz PHONE NO : 949 5852406 15285 Alton Parkway, Suite 200 SE DECISION MADE: 06‐AUG‐15Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q‐Rad Radiographic System with Auto‐Tracker OptionQUANTUM MEDICAL IMAGING DIVISON OF510(k) NO: K151924 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151924.pdf)(Special)ATTN: MARK CAMIRAND PHONE NO : 631 7377237 2002‐B ORVILLE DRIVE NORTH SE DECISION MADE: 07‐AUG‐15RONKONKOMA NY 11779 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWAREPERSYST DEVELOPMENT CORPORATION 510(k) NO: K151929 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151929.pdf)(Special)ATTN: DARI DARABBEIGI PHONE NO : 858 4614542 10912625 HIGH BLUFF DRIVE, SUITE 213 SE DECISION MADE: 12‐AUG‐15SAN DIEGO CA 92130 510(k) STATEMENT DEVICE: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood OnlyALERE SAN DIEGO, INCORPORATED 510(k) NO: K151935 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151935.pdf)(Special)
ATTN: JOSEPH DE LA ROSA PHONE NO : 1 858 8053181 9975 SUMMERS RIDGE ROAD SE DECISION MADE: 12‐AUG‐15SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LightSheer Desire Light Laser SystemLUMENIS LTD 510(k) NO: K151947 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151947.pdf)(Special)ATTN: ELISSA BURG PHONE NO : 972 4 9599168 6 HAKIDMA STREET PO BOX 240, YOKNESE DECISION MADE: 12‐AUG‐15YOKNEAM IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical Inc. 510(k) NO: K151961 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151961.pdf)(Special)ATTN: Meghan M Leonard PHONE NO : 440 9426161 7893 Enterprise Drive SE DECISION MADE: 18‐AUG‐15Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Turnpike catheterVASCULAR SOLUTION, INC. 510(k) NO: K151981 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151981.pdf)(Special)ATTN: BEKA VITE PHONE NO : 763 6464300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 13‐AUG‐15MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TraceIT Tissue Marker ‐ 3mLAUGMENIX, INC. 510(k) NO: K151998 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151998.pdf)(Special)ATTN: NOEL ROLON PHONE NO : 781 9021616 204 SECOND AVENUE, LOWER LEVEL SE DECISION MADE: 19‐AUG‐15WALTHAM MA 02451 510(k) STATEMENT DEVICE: Cook ECM PowderCook Biotech Incorporated 510(k) NO: K152033 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152033.pdf)(Special)ATTN: Perry W Guinn PHONE NO : 765 4973355 1425 Innovation Place SE DECISION MADE: 19‐AUG‐15West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexor Radial Hydrophilic Introducer Access SetCOOK INCORPORATED 510(k) NO: K152044 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152044.pdf)(Special)ATTN: SARAH REEVES PHONE NO : 812 3353575 105024750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 14‐AUG‐15BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALVATION® External Fixation SystemWRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K152045(Special)ATTN: JEANINE REDDEN PHONE NO : 901 8674522 1023 CHERRY ROAD SE DECISION MADE: 21‐AUG‐15MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Confida Adaptive SheathMedtronic, Inc. 510(k) NO: K152054(Third Party ‐ Traditional)ATTN: Matthew Lobeck PHONE NO : 763 5267890 710 Medtronic Parkway SE DECISION MADE: 07‐AUG‐15Minneapolis MN 55432 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BioZorb LP MarkerFocal Terapeutics 510(k) NO: K152070 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152070.pdf)(Special)ATTN: George Hermann PHONE NO : 650 5302394 4370 Alpine Rd. #101 SE DECISION MADE: 26‐AUG‐15Portola Valley CA 94028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NovaBone MacroFORM MIS Composite ‐ 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)NOVABONE PRODUCTS, LLC 510(k) NO: K152071 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152071.pdf)(Special)ATTN: RICHARD A. DAVIS PHONE NO : 386 4621010 13510 NW US HIGHWAY 441 SE DECISION MADE: 26‐AUG‐15ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker 510(k) NO: K152076
(http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152076.pdf)(Special)ATTN: Jonathan Schell PHONE NO : 269 3895596 750 TRADE CENTRE WAY SUITE 200 SE DECISION MADE: 26‐AUG‐15PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Weck Auto Endo5 Hem‐o‐lok Ligating Clip ApplierTeleflex Medical, Inc. 510(k) NO: K152081 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152081.pdf)(Special)ATTN: Ashlea Ricci PHONE NO : 919 4338065 3015 Carrington Mill Blvd SE DECISION MADE: 26‐AUG‐15Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Retraction AspiratorINARI MEDICAL 510(k) NO: K152097 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152097.pdf)(Special)ATTN: EBEN GORDON PHONE NO : 949 6008433 9272 JERONIMO RD., SUITE 124 SE DECISION MADE: 25‐AUG‐15IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5.5 F Worley Advanced LVI Lateral Vein IntroducerMERIT MEDICAL SYSTEMS, INC. 510(k) NO: K152116(Special)ATTN: ALINA STUBBS PHONE NO : 610 6515046 65 GREAT VALLEY PARKWAY SE DECISION MADE: 27‐AUG‐15MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual‐ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual‐ICE SystemGALIL MEDICAL LTD 510(k) NO: K152133 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152133.pdf)(Special)ATTN: LYNNE DAVIES PHONE NO : 651 2875098 TAVOR 1 BUILDING SE DECISION MADE: 28‐AUG‐15SHAAR YOKNEAM IL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S8 Exp/S9 Portable Digital Color Doppler Ultrasound SystemSONOSCAPE MEDICAL CORP. 510(k) NO: K152164 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152164.pdf)(Special)ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f, Yizhe BSE DECISION MADE: 28‐AUG‐15Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S9 Portable Digital Color Doppler Ultrasound SystemSONOSCAPE MEDICAL CORP. 510(k) NO: K152165 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152165.pdf)(Special)ATTN: Toki Wu PHONE NO : 86 755 26722890 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe BSE DECISION MADE: 26‐AUG‐15Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sniper Spine SystemSPINE WAVE, INC. 510(k) NO: K152174 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152174.pdf)(Special)ATTN: Sanja Jahr PHONE NO : 203 9449494 3 ENTERPRISE DRIVE, SUITE 210 SE DECISION MADE: 31‐AUG‐15SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HealthMyne PACSHEALTHMYNE, INC. 510(k) NO: K152186 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152186.pdf)(Third Party ‐ Traditional)ATTN: SIGRID SCHOEPEL PHONE NO : 608 8332610 918 DEMING WAY SE DECISION MADE: 20‐AUG‐15MADISON WI 53717 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FUJIFILM SonoSite X‐Porte Ultrasound SystemFUJIFILM SONOSITE,INC. 510(k) NO: K152209 (http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152209.pdf)(Third Party ‐ Traditional)ATTN: PATRICIA LIAU PHONE NO : 425 9516870 21919 30th Dr SE SE DECISION MADE: 19‐AUG‐15BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW TOTAL 510(k)s THIS PERIOD 234 TOTAL WITH SUMMARIES 214 TOTAL WITH STATEMENTS 20