FDA 510(k) Application Details - K191485

Device Classification Name	Endoscopic Cytology Brush   More FDA Info for this Device
510(K) Number	K191485
Device Name	Endoscopic Cytology Brush
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47404 US Other 510(k) Applications for this Company
Contact	Irasema Rivera 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	06/04/2019
Decision Date	06/26/2019
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