FDA 510(k) Application Details - K143018

Device Classification Name	More FDA Info for this Device
510(K) Number	K143018
Device Name	Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
Applicant	Covidien 15 Hampshire Street Mansfeild, MA 02048 US Other 510(k) Applications for this Company
Contact	Wei Zhao 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	10/20/2014
Decision Date	04/02/2015
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