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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

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Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Pages 30 through 33 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)(b) (4)-Sub-contractor material testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Pages 37 through 38 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)- testing

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Pages 44 through 46 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)- material testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Pages 55 through 56 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)-l testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Pages 58 through 65 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)-l testing data

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Pages 97 through 114 redacted for the following reasons:- - - - - - - - - - - - - - - - - - - - - - - - - - - -(b) (4), (b) (4)-Engineering Drawings

Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118