FDA 510(k) Application Details - K181909

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K181909
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	UVision360 Inc. 4441-106 Six Forks Road, #179 Raleigh, NC 27609 US Other 510(k) Applications for this Company
Contact	Allison London Brown Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2018
Decision Date	08/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review