FDA 510(k) Application Details - K071048

Device Classification Name Instrument, Biopsy

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510(K) Number K071048
Device Name Instrument, Biopsy
Applicant RUBICOR MEDICAL, INC.
25 HARTFORD AVE.
SAN CARLOS, CA 94070 US
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Contact ROBERT J CHIN
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 04/13/2007
Decision Date 05/15/2007
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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