FDA 510(k) Application Details - K101095

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K101095
Device Name	Catheter, Biliary, Diagnostic
Applicant	WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD WINSTON SALEM, NC US Other 510(k) Applications for this Company
Contact	SCOTTIE FARIOLE 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	04/20/2010
Decision Date	07/19/2010
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