FDA.reportPublic FDA data

510(k) K954743

Device
DERMAGRAN WOUND DRESSING CLEANER W/ZINC
Applicant
DERMA SCIENCES, INC.
510(k) number
K954743
Product code
MGP  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-02
Date received
1995-10-16
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound And Burn, Occlusive
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HOWARD ENFIEJIAN
Address
121 W. Grace St. Old Forge PA US 18518 18518

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MGP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012995COLLATEK SHEETBiocore Medical Technologies, Inc.2001-10-25
K012997COLLATEK FOAMBiocore Medical Technologies, Inc.2001-10-25
K001508LASERSKIN DRESSINGFidia Advanced Biopolymers Srl2001-07-25
K990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.1999-12-23
K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.1999-10-14
K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, Inc.1999-09-14
K992005GILTECH PLUS TRANSPARENT DRESSINGGiltech Plus, Inc.1999-09-03
K990875DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSINGDermaphylyx, Inc.1999-05-27
K990438DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSINGDermaphylyx, Inc.1999-03-25
K984371MEPITEL NON ADHERENT SILICONE DRESSINGMolnlycke Health Care, Inc.1999-03-03
K983303INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGSInnovative Technologies , Ltd.1998-12-09
K983234TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSINGJohnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-25
K983394MODIFICATION TO TIELLE HYDROPOLMER DRESSINGJohnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-03
K983184MEPILEXMolnlycke Health Care, Inc.1998-10-28
K974891ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013Acutek Adhesive Specialties, Inc.1998-10-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases