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

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
K971597	COLOPLAST CORP.	COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)	07/29/1997
K991061	DERMAPHYLYX, INC.	DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING	06/28/1999
K992094	GILTECH PLUS, INC.	GILTECH PLUS HYDROGEL SKIN DRESSING	09/17/1999
K082865	GORBEC PHARMACEUTICAL SERVICES, INC.	MODIFICATION TO ZENIEVA	10/23/2008
K073246	GORBEC PHARMACEUTICAL SERVICES, INC.	ZENIEVA	07/23/2008
K972646	LUDLOW TECHNICAL PRODUCTS	AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES	08/21/1997
K962352	NORTH AMERICAN STERILIZATION & PACKAGING CO.	HYDROGEL SKIN DRESSING	08/02/1996
K083721	RIVER'S EDGE PHARMACEUTICALS, LLC	MODIFICATION TO ZENIEVA	01/08/2009