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FDA 510(k) Application Details - K063677
Device Classification Name
Catheter, Biliary, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
GCA
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More FDA Info for this Product Code
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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