FDA 510(k) Applications for Medical Device Product Code "MGP"
(Dressing, Wound And Burn, Occlusive)

FDA 510(k) Number Applicant Device Name Decision Date
K973036 3M HEALTH CARE 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES 11/12/1997
K974892 ACUTEK ADHESIVE SPECIALTIES, INC. ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 10/13/1998
K974891 ACUTEK ADHESIVE SPECIALTIES, INC. ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 10/21/1998
K974890 ACUTEK ADHESIVE SPECIALTIES, INC. ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 10/13/1998
K973260 AVITAR, INC. HYDRASORB STERILE DRESSING 10/21/1997
K960847 BELLINGHAM MEDICAL, INC. DERMASEAL 04/04/1996
K012997 BIOCORE MEDICAL TECHNOLOGIES, INC. COLLATEK FOAM 10/25/2001
K012995 BIOCORE MEDICAL TECHNOLOGIES, INC. COLLATEK SHEET 10/25/2001
K982939 BIODERM, INC. BTF THIN FILM WOUND DRESSING 10/13/1998
K961319 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS EPIVIEW 07/08/1996
K972458 COURTAULDS FIBERS, INC. LYOCELL WOUND DRESSING/SURGICAL SPONGE 09/19/1997
K990438 DERMAPHYLYX, INC. DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING 03/25/1999
K990875 DERMAPHYLYX, INC. DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING 05/27/1999
K992302 DERMAPHYLYX, INC. DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS 09/14/1999
K955476 DUKAL CORP. DUKAL TRANSPARENT WOUND DRESSING 01/18/1996
K960393 EUROMED A/S SURESKIN BORDER 03/01/1996
K960394 EUROMED A/S SURESKIN STANDARD 03/01/1996
K960404 EUROMED A/S SURESKIN THIN 03/01/1996
K001508 FIDIA ADVANCED BIOPOLYMERS SRL LASERSKIN DRESSING 07/25/2001
K992005 GILTECH PLUS, INC. GILTECH PLUS TRANSPARENT DRESSING 09/03/1999
K990079 GREENFIELD MEDICAL TECHNOLOGIES, INC. FASTSEAL CHEST WOUND DRESSING 12/23/1999
K980209 HOLLISTER, INC. SIMPLICARE THIN FILM WOUND DRESSINGS 02/20/1998
K991214 HOLLISTER, INC. SIMPLICARE TRANSPARENT WOUND DRESSING 10/14/1999
K974520 INNOVATIVE TECHNOLOGIES (US), INC. SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM 02/06/1998
K983303 INNOVATIVE TECHNOLOGIES LTD. INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS 12/09/1998
K981753 INNOVATIVE TECHNOLOGIES LTD. INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING 06/30/1998
K973312 INNOVATIVE TECHNOLOGIES LTD. TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING 10/22/1997
K983394 JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. MODIFICATION TO TIELLE HYDROPOLMER DRESSING 11/03/1998
K983234 JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING 11/25/1998
K961098 K. W. GRIFFEN CO. BIO-DRESSING, STERILE ISLAND DRESSING 05/03/1996
K970518 LABORATOIRES URGO S.A. ALGOPLAQUE HYDROCOLLOID DRESSING 03/21/1997
K973657 MAERSK MEDICAL, LTD. ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING 12/01/1997
K983184 MOLNLYCKE HEALTH CARE, INC. MEPILEX 10/28/1998
K984371 MOLNLYCKE HEALTH CARE, INC. MEPITEL NON ADHERENT SILICONE DRESSING 03/03/1999
K963753 NORTH AMERICAN STERILIZATION & PACKAGING CO. NASP TRANSPARENT DRESSING 11/29/1996
K971093 OPPORTUNITY, INC. OPPORTUNITY I.V. START KIT 09/16/1997
K963623 POLYMEDICA INDUSTRIES, INC. SPYROFLEX PIGMENTED WOUND DRESSING 10/25/1996
K964398 POLYMEDICA INDUSTRIES, INC. SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED 10/24/1997
K981713 SMITH & NEPHEW, INC. CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 07/31/1998
K973538 WINFIELD LABORATORIES, INC. N-TERFACE 12/16/1997


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