FDA 510(k) Application Details - K193344

Device Classification Name	Catheter, Biliary, Surgical   More FDA Info for this Device
510(K) Number	K193344
Device Name	Catheter, Biliary, Surgical
Applicant	Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Theresa de Prat Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	GCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2019
Decision Date	12/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review