FDA 510(k) Application Details - K140085

Device Classification Name	Catheter, Malecot   More FDA Info for this Device
510(K) Number	K140085
Device Name	Catheter, Malecot
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	ELYSIA EASTON Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	FEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2014
Decision Date	11/18/2014
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