Konix Anti-Fog Solution— 510(k) K190864

Name: FDA 510(k) clearance K190864
Creator: U.S. Food and Drug Administration
Published: 2020-08-27

Substantially Equivalent

Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler

FDA 510(k) clearance K190864 for Konix Anti-Fog Solution, Substantially Equivalent on 2020-08-27. Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. Device class: 2.

Clearance details

Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-03
Decision date: 2020-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.