FDA 510(k) Application Details - K162906

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K162906
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	ConvaTec GDC, First Avenue, Deeside Industrial Park Deeside ch5 2nu GB Other 510(k) Applications for this Company
Contact	Karen Howes Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2016
Decision Date	03/07/2017
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