FDA 510(k) Application Details - K031360

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K031360
Device Name	Catheter, Biliary, Diagnostic
Applicant	GI SUPPLY 25 VILLAGE HILL ROAD WILLINGTON, CT 06279 US Other 510(k) Applications for this Company
Contact	ROB WHALEN 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	04/30/2003
Decision Date	09/24/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review