FDA 510(k) Application Details - K092059

Device Classification Name Instrument, Biopsy

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510(K) Number K092059
Device Name Instrument, Biopsy
Applicant RIVERPOINT MEDICAL
825 NE 25TH AVE.
PORTLAND, OR 97232 US
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Contact DOUG ROWLEY
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 07/07/2009
Decision Date 09/24/2009
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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