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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K983519
Device Name COMFEEL SEASORB DRESSING
Applicant
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062 -2249
Applicant Contact M.SYDNEY LILLY
Correspondent
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062 -2249
Correspondent Contact M.SYDNEY LILLY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/08/1998
Decision Date 12/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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