FDA 510(k) Application Details - K190864

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K190864
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San. ve Tic. LTD No. 34 Beylikduzu Istanbul 34524 TR Other 510(k) Applications for this Company
Contact	Nurham Irmak 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	04/03/2019
Decision Date	08/27/2020
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