FDA 510(k) Application Details - K111100

Device Classification Name Instrument, Biopsy

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510(K) Number K111100
Device Name Instrument, Biopsy
Applicant C.R. BARD, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281-1740 US
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Contact JUSTIN LOVELACE
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 04/20/2011
Decision Date 06/16/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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