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510(k) K971597

Device
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
Applicant
COLOPLAST CORP.
510(k) number
K971597
Product code
MGQ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-29
Date received
1997-05-01
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
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
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD A HAMER
Address
6401 Meadows W. Dr. Fort Worth TX US 76132 76132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MGQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171879HylaGuard Moisturizing CreamFounders Science Group, LLC2017-10-16
K083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical Incorporated2009-03-27
K041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.2005-07-19
K041268SILVERSITE OR CALGITROLAdri2004-09-20
K040019SILVERSEALNoble Fiber Technologies2004-07-23
K040517TENDERWET ACTIVEMedline Industries, Inc.2004-03-25
K022587MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGSMedtrade Products , Ltd.2003-08-22
K024367SINCLAIR WOUND AND SKIN EMULSIONSinclair Pharmaceuticals, Ltd.2003-07-28
K024054XYLOS XCELL ANTIMICROBIAL DRESSINGXylos Corporation2003-03-07
K022584CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSINGCardiotech Intl.2002-12-30
K022995COLLATEK HYDROGELBiocore Medical Technologies, Inc.2002-12-02
K013525CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)Coloplast Corp.2002-10-04
K020325L.A.M. IPM WOUND GELL.A.M. Pharmaceutical, Corp.2002-04-15
K011994ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101Acrymed, Inc.2001-11-08
K010583AMBU GEL, HYDROGEL BURN DRESSINGAmbu, Inc.2001-05-25

Legacy Summary#

summary

FDA Review#

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