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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 K970453
Device Name B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
Applicant
B. Braun Medical, Inc.
727 W. Glendale Ave.
Milwaukee,  WI  53209
Applicant Contact DIANE HOCHREIN
Correspondent
B. Braun Medical, Inc.
727 W. Glendale Ave.
Milwaukee,  WI  53209
Correspondent Contact DIANE HOCHREIN
Classification Product Code
MGQ  
Date Received01/22/1997
Decision Date 04/11/1997
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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