FDA 510(k) Application Details - K133334

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K133334
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	VERITRACT, INC. 383 COLOROW DRIVE SALT LAKE CITY, UT 84108 US Other 510(k) Applications for this Company
Contact	TIM NIEMAN 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	10/29/2013
Decision Date	08/26/2014
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	Y
Expedited Review