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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K945850
Device Name BRAUN DIACAN(R) FISTULA NEEDLES
Applicant
B. BRAUN OF AMERICA, INC.
824 TWELFTH AVE.
PO BOX 4027
BETHLEHEM,  PA  18018 -0027
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN OF AMERICA, INC.
824 TWELFTH AVE.
PO BOX 4027
BETHLEHEM,  PA  18018 -0027
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5540
Classification Product Code
FIE  
Date Received11/30/1994
Decision Date 10/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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