FDA 510(k) Application Details - K142297

Device Classification Name	More FDA Info for this Device
510(K) Number	K142297
Device Name	Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
Applicant	XERIDIEM (FORMERLY MRI) 4700 S. OVERLAND DR. TUCSON, AZ 85714 US Other 510(k) Applications for this Company
Contact	Jesus Valencia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2014
Decision Date	01/08/2015
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