FDA 510(k) Application Details - K120452

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K120452
Device Name	Catheter, Biliary, Diagnostic
Applicant	FLEXIBLE STENTING SOLUTIONS, INC. 23 CHRISTOPHER WAY SUITE 103 EATONTOWN, NJ 07724 US Other 510(k) Applications for this Company
Contact	JOSEPH C GRIFFIN III 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	02/14/2012
Decision Date	04/24/2012
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