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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K883374
Device Name BARD BIOPSY NEEDLE GUIDANCE DEVICE
Applicant
C.R. BARD, INC.
5 FEDERAL ST.
P.O. BOX 5069
BILLERICA,  MA  01822
Applicant Contact ERNEST MANFREDO
Correspondent
C.R. BARD, INC.
5 FEDERAL ST.
P.O. BOX 5069
BILLERICA,  MA  01822
Correspondent Contact ERNEST MANFREDO
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/09/1988
Decision Date 09/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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