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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K990368
Device Name DUODERM HYDROACTIVE GEL WOUND DRESSING
Applicant
Convatec, A Bristol-Myers Squibb Co.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact ADRIENNE MCNALLY
Correspondent
Convatec, A Bristol-Myers Squibb Co.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact ADRIENNE MCNALLY
Classification Product Code
MGQ  
Date Received02/08/1999
Decision Date 03/26/1999
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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