FDA 510(k) Application Details - K173654

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K173654
Device Name	Dilator, Catheter, Ureteral
Applicant	Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404 US Other 510(k) Applications for this Company
Contact	Kotei Aoki Other 510(k) Applications for this Contact
Regulation Number	876.5470   More FDA Info for this Regulation Number
Classification Product Code	EZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2017
Decision Date	07/17/2018
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