FDA 510(k) Application Details - K132686

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K132686
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	DEGANIA SILICONE, LTD. DEGANIA BET EMEK HAYARDEN 15130 IL Other 510(k) Applications for this Company
Contact	ZOYA LEE 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	08/28/2013
Decision Date	05/12/2014
Decision	SESK - SUBST EQUIV - KIT
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