FDA 510(k) Application Details - K081996

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K081996
Device Name	Catheter, Biliary, Diagnostic
Applicant	FLEXIBLE STENTING SOLUTIONS, INC. 23 CHRISTOPHER WAY EATONTOWN, NJ 07724 US Other 510(k) Applications for this Company
Contact	JOSEPH C GRIFFIN 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	07/14/2008
Decision Date	09/15/2009
Decision	SESU - SE - WITH LIMITATIONS
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