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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 kit
510(k) Number K910720
Device Name BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
Original Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington,  GA  30014
Original Contact donna j wilson
Regulation Number876.1075
Classification Product Code
FCG  
Date Received02/20/1991
Decision Date 06/10/1991
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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