FDA 510(k) Application Details - K113872

Device Classification Name Instrument, Biopsy

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510(K) Number K113872
Device Name Instrument, Biopsy
Applicant VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GRACE HOLLAND
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 12/30/2011
Decision Date 03/08/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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