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.
| Device ID | K190864 |
| 510k Number | K190864 |
| Device Name: | Konix Anti-Fog Solution |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler San. Ve Tic. LTD No. 34 Beylikduzu Istanbul, TR 34524 |
| Contact | Nurham Irmak |
| Correspondent | Ronald J. Amen ST&T Research, Inc. 18101 Catherine Circle Villa Park, CA 92861 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-03 |
| Decision Date | 2020-08-27 |