FDA 510(k) Application Details - K063677

Device Classification Name Catheter, Biliary, Surgical

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510(K) Number K063677
Device Name Catheter, Biliary, Surgical
Applicant WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM, NC 27105 US
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Contact SCOTTIE FARIOLE
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Regulation Number 876.5010

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Classification Product Code GCA
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Date Received 12/11/2006
Decision Date 01/05/2007
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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