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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 K973688
Device Name DUODERM CONTROL GEL FORMULA BORDER DRESSING
Applicant
Convatec, Ltd.
100 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact ANDRIENNE MCNALLY
Correspondent
Convatec, Ltd.
100 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact ANDRIENNE MCNALLY
Classification Product Code
FRO  
Date Received09/26/1997
Decision Date 12/23/1997
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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