FDA 510(k) Application Details - K162254

Device Classification Name	More FDA Info for this Device
510(K) Number	K162254
Device Name	Cedic Enteral ENFit Transition Connectors
Applicant	CEDIC S.R.L. VIA LIBERAZIONE, 63/9 PESCHIERA BORROMEO 20068 IT Other 510(k) Applications for this Company
Contact	TIZIANA MELIS 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	08/10/2016
Decision Date	05/04/2017
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