FDA 510(k) Applications for Medical Device Product Code "NAE"
(Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic)

FDA 510(k) Number Applicant Device Name Decision Date
K082865 GORBEC PHARMACEUTICAL SERVICES, INC. MODIFICATION TO ZENIEVA 10/23/2008
K073246 GORBEC PHARMACEUTICAL SERVICES, INC. ZENIEVA 07/23/2008
K083721 RIVER'S EDGE PHARMACEUTICALS, LLC MODIFICATION TO ZENIEVA 01/08/2009


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