FDA 510(k) Application Details - K080171

Device Classification Name Instrument, Biopsy

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510(K) Number K080171
Device Name Instrument, Biopsy
Applicant SANARUS MEDICAL, INC.
4696 WILLOW RD.
PLEASANTON, CA 94588 US
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Contact LISA HENRY
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 01/24/2008
Decision Date 03/06/2008
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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