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The top documents tagged [marketed predicate device]
Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering
[email protected]
Director, International Staff US Food and Drug Administration
226 views
GU Advisory Panel Meeting GU Advisory Panel Meeting Nocturnal Home Hemodialysis Carolyn Y. Neuland, Ph.D. Chief, Gastroenterology and Renal Devices Branch
222 views
FDA 510K Clearance Documentation K031759 Cups Device Modification Drug Testing Kits
236 views