FDA 510(k) Application Details - K163257

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K163257
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	SiO2 Nanotech, LLC 275 N. GATEWAY DRIVE SUITE 126 PHOENIX, AZ 85034 US Other 510(k) Applications for this Company
Contact	CLARIZZA WATSON Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2016
Decision Date	05/24/2017
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