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510(k) K990438

Device
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
Applicant
DERMAPHYLYX, INC.
510(k) number
K990438
Product code
MGP  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-25
Date received
1999-02-11
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANDREW M REED
Address
12106 W. 75th Ln. Arvada CO US 80005 80005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K982939BTF THIN FILM WOUND DRESSINGBioderm, Inc.1998-10-13

Legacy Summary#

summary

FDA Review#

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