FDA 510(k) Application Details - K131183

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K131183
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	BENLAN, INC. 2760 BRIGHTON RD. OAKVILLE, ONTARIO L6H 5T4 CA Other 510(k) Applications for this Company
Contact	CHERYL BROWN Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2013
Decision Date	06/03/2014
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