FDA 510(k) Application Details - K171347

Device Classification Name	More FDA Info for this Device
510(K) Number	K171347
Device Name	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Applicant	Xeridiem Medical Devices 4700 S. Overland Dr. Tucson, AZ 85714 US Other 510(k) Applications for this Company
Contact	Steve Murray 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	05/08/2017
Decision Date	06/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review