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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K950982
Device Name B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
Applicant
B. BRAUN OF AMERICA, INC.
824 12TH AVE.
BETHLEHEM,  PA  18018
Applicant Contact JONAS D WILF
Correspondent
B. BRAUN OF AMERICA, INC.
824 12TH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact JONAS D WILF
Regulation Number876.1075
Classification Product Code
FCG  
Date Received03/03/1995
Decision Date 04/04/1995
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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