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FDA 510(k) Application Details - K040129
Device Classification Name
Catheter, Biliary, Surgical
More FDA Info for this Device
510(K) Number
K040129
Device Name
Catheter, Biliary, Surgical
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM, NC 27105 US
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Contact
MARGE WALLS-WALKER
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
GCA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2004
Decision Date
02/27/2004
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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