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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 K983173
Device Name BIATAIN FOAM ADHESIVE DRESSING
Applicant
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062
Applicant Contact M. SYDNEY LILLY
Correspondent
Coloplast Corp.
1955 W. Oak Cir.
Marietta,  GA  30062
Correspondent Contact M. SYDNEY LILLY
Classification Product Code
FRO  
Date Received09/10/1998
Decision Date 12/16/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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