FDA 510(k) Application Details - K140953

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K140953
Device Name	Catheter, Urological
Applicant	CONVATEC LTD. UNIT 20, FIRST AVENUE, DEESIDE INDUSTRIAL PARK DEESIDE CH5 2NU GB Other 510(k) Applications for this Company
Contact	CLARE WILLIAMSON 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	04/14/2014
Decision Date	08/01/2014
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