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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 K133948
FOIA Releasable 510(k) K133948
Device Name BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
Applicant
BARD PERIPHERAL VASCULAR, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281
Applicant Contact SARAH MCCARTNEY
Correspondent
BARD PERIPHERAL VASCULAR, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281
Correspondent Contact SARAH MCCARTNEY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received12/23/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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