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

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K971597 COLOPLAST CORP. 6401 MEADOWS WEST DR.
FORT WORTH TX 76132
K991061 DERMAPHYLYX, INC. 78-E,, OLYMPIA AVE.
WOBURN MA 01801-3933
K992094 GILTECH PLUS, INC. P.O. BOX 728
MILFORD PA 18337
K082865 GORBEC PHARMACEUTICAL SERVICES, INC. 2445 SOUTH ALSTON AVENUE
DURHAM NC 27713
K073246 GORBEC PHARMACEUTICAL SERVICES, INC. 2445 SOUTH ALSTON AVENUE
DURHAM NC 27713
K972646 LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK
CHICOPEE MA 01022
K962352 NORTH AMERICAN STERILIZATION & PACKAGING CO. 18 WHITE LAKE RD.
SPARTA NJ 07871
K083721 RIVER'S EDGE PHARMACEUTICALS, LLC 2445 SOUTH ALSTON AVE.
DURHAM NC 27713




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