The following data is part of a premarket notification filed by Sio2 Nanotech, Llc with the FDA for Vitreox Anti-fog Solution.
| Device ID | K163257 |
| 510k Number | K163257 |
| Device Name: | VitreOx Anti-fog Solution |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | SiO2 Nanotech, LLC 275 N. GATEWAY DRIVE SUITE 126 Phoenix, AZ 85034 |
| Contact | Clarizza Watson |
| Correspondent | Clarizza Watson SiO2 Nanotech, LLC 275 N. GATEWAY DRIVE SUITE 126 Phoenix, AZ 85034 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-05-24 |
| Summary: | summary |