FDA 510(k) Application Details - K171600

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K171600
Device Name	Catheter, Urological
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47404 US Other 510(k) Applications for this Company
Contact	Samuel Engelman 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	06/01/2017
Decision Date	02/16/2018
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