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FDA 510(k) Application Details - K171548
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K171548
Device Name
Catheter, Biliary, Diagnostic
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem, NC 57105 US
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Contact
Sierra Lowe
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
FGE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/2017
Decision Date
10/13/2017
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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