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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Hydrogel Without Drug And/Or Biologic
510(k) Number K971597
Device Name COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
Applicant
Coloplast Corp.
6401 Meadows W. Dr.
Fort Worth,  TX  76132
Applicant Contact RICHARD A HAMER
Correspondent
Coloplast Corp.
6401 Meadows W. Dr.
Fort Worth,  TX  76132
Correspondent Contact RICHARD A HAMER
Regulation Number878.4022
Classification Product Code
NAE  
Date Received05/01/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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