FDA 510(k) Application Details - K142012

Device Classification Name	More FDA Info for this Device
510(K) Number	K142012
Device Name	FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
Applicant	CORPAK MEDSYSTEMS 1001 ASBURY DR. BUFFALO GROVE, IL 60089 US Other 510(k) Applications for this Company
Contact	STEPHANIE WASIELEWKI 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	07/24/2014
Decision Date	11/20/2014
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	N
Expedited Review