FDA 510(k) Application Details - K173009

Device Classification Name	Dislodger, Stone, Biliary   More FDA Info for this Device
510(K) Number	K173009
Device Name	Dislodger, Stone, Biliary
Applicant	Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Colin Jacob Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	LQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2017
Decision Date	11/07/2017
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