FDA 510(k) Application Details - K173035

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K173035
Device Name	Catheter, Biliary, Diagnostic
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Erum B. Nasir Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2017
Decision Date	05/01/2018
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