FDA 510(k) Application Details - K161344

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K161344
Device Name	Catheter, Urological
Applicant	CONVATEC LIMITED GDC, FIRST AVENUE, DEESIDE INDUSTRIAL PARK DEESIDE CH5 2NU GB Other 510(k) Applications for this Company
Contact	ELINOR JONES Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2016
Decision Date	09/20/2016
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