FDA 510(k) Application Details - K053245

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K053245
Device Name	Catheter, Biliary, Diagnostic
Applicant	URESIL, LLC 5418 WEST TOUHY AVE. SKOKIE, IL 60077 US Other 510(k) Applications for this Company
Contact	MATTHEW MAHON 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	11/21/2005
Decision Date	12/20/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review