FDA 510(k) Application Details - K160890

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K160890
Device Name	Kit, Needle, Biopsy
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	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2016
Decision Date	06/14/2017
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