FDA 510(k) Application Details - K191048

Device Classification Name	Snare, Flexible   More FDA Info for this Device
510(K) Number	K191048
Device Name	Snare, Flexible
Applicant	Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 US Other 510(k) Applications for this Company
Contact	Doris A. Hawks Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2019
Decision Date	07/18/2019
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