Konix Anti-Fog Solution

Anti Fog Solution And Accessories, Endoscopy

Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler

The following data is part of a premarket notification filed by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler with the FDA for Konix Anti-fog Solution.

Pre-market Notification Details

Device IDK190864
510k NumberK190864
Device Name:Konix Anti-Fog Solution
ClassificationAnti Fog Solution And Accessories, Endoscopy
Applicant Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San. Ve Tic. LTD No. 34 Beylikduzu Istanbul,  TR 34524
ContactNurham Irmak
CorrespondentRonald J. Amen
ST&T Research, Inc. 18101 Catherine Circle Villa Park,  CA  92861
Product CodeOCT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-03
Decision Date2020-08-27

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