The following data is part of a premarket notification filed by Titmus Optical, Inc. with the FDA for Cristy/cote.
| Device ID | K843096 |
| 510k Number | K843096 |
| Device Name: | CRISTY/COTE |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | TITMUS OPTICAL, INC. Petersburg , VA 23804 - |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-07 |
| Decision Date | 1984-11-21 |