FDA 510(k) Application Details - K163586

Device Classification Name	More FDA Info for this Device
510(K) Number	K163586
Device Name	Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
Applicant	TrovRx, Inc. dba Trovita Health Science 230 South Broad Street, 17th Floor Philadelphia, PA 19102 US Other 510(k) Applications for this Company
Contact	William Brown 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	12/20/2016
Decision Date	03/17/2017
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