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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K973227
Device Name ASKINA HYDROCOLLOID/THIN
Applicant
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5090
Classification Product Code
KMF  
Date Received08/27/1997
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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