FDA 510(k) Application Details - K071814

Device Classification Name Instrument, Biopsy

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510(K) Number K071814
Device Name Instrument, Biopsy
Applicant MINRAD, INC.
50 COBHAM DR.
ORCHARD PARK, NY 14127-4121 US
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Contact JOHN MCNEIRNEY
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 07/02/2007
Decision Date 10/16/2007
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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