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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K920675
Device Name DUODERM SUSTAINED COMPRESSION BANDAGE
Applicant
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Applicant Contact STEVEN PELTIER
Correspondent
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Correspondent Contact STEVEN PELTIER
Regulation Number880.5240
Classification Product Code
KGX  
Date Received02/14/1992
Decision Date 08/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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