Documents Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative...

Slide 1Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Food and…

Documents FDA 510K Clearance Documentation K031759 Cups Device Modification Drug Testing Kits

SPECIAL 510(k): Device Modification ODE Review Memorandum To: THE FILE RE: DOCUMENT NUMBER K 031759 This 510(k) submission contains information/data on modifications made…