FDA 510(k) Application Details - K151237

Device Classification Name	More FDA Info for this Device
510(K) Number	K151237
Device Name	Nutrisafe 2- ENFit Adaptor
Applicant	VYGON 2750 MORRIS ROAD, SUITE A200 LANSDALE, PA 19446 US Other 510(k) Applications for this Company
Contact	Jillian Mikovich Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2015
Decision Date	02/09/2016
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