FDA 510(k) Application Details - K192908

Device Classification Name	Endoscopic Cytology Brush   More FDA Info for this Device
510(K) Number	K192908
Device Name	Endoscopic Cytology Brush
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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2019
Decision Date	11/14/2019
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