FDA 510(k) Application Details - K171969

Device Classification Name	Dislodger, Stone, Biliary   More FDA Info for this Device
510(K) Number	K171969
Device Name	Dislodger, Stone, Biliary
Applicant	Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Ashley Howard 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	06/30/2017
Decision Date	03/28/2018
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