FDA 510(k) Application Details - K142539

Device Classification Name	More FDA Info for this Device
510(K) Number	K142539
Device Name	EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
Applicant	ZEVEX, INC. 4314 ZEVEX PARK LN. SALT LAKE CITY, UT 84123 US Other 510(k) Applications for this Company
Contact	Dianne Batch 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	09/09/2014
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