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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, Drug
510(k) Number K982493
Device Name COMPEED PSORIASIS DRESSING
Applicant
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062 -2249
Applicant Contact SYDNEY LILLY
Correspondent
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062 -2249
Correspondent Contact SYDNEY LILLY
Classification Product Code
FRO  
Date Received07/17/1998
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
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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