FDA 510(k) Application Details - K040842

Device Classification Name Instrument, Biopsy

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510(K) Number K040842
Device Name Instrument, Biopsy
Applicant SENORX, INC.
11 COLUMBIA, SUITE A
ALISO VIEJO, CA 92656 US
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Contact AMY BOUCLY
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 04/01/2004
Decision Date 04/30/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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