FDA 510(k) Application Details - K182381

Device Classification Name	Dislodger, Stone, Biliary   More FDA Info for this Device
510(K) Number	K182381
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	Tiffanny A. Thomas 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	08/31/2018
Decision Date	10/30/2018
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