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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 K912667
Device Name DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS
Applicant
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Applicant Contact MARILYN B DREYLING
Correspondent
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Correspondent Contact MARILYN B DREYLING
Classification Product Code
MGQ  
Date Received06/18/1991
Decision Date 09/04/1991
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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