The following data is part of a premarket notification filed by Ramada Optics, Inc. with the FDA for Optical Frames.
| Device ID | K945770 |
| 510k Number | K945770 |
| Device Name: | OPTICAL FRAMES |
| Classification | Frame, Spectacle |
| Applicant | RAMADA OPTICS, INC. 22751 SUITE E MANDEVILLE PLACE Boca Raton, FL 33433 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-02 |
| Decision Date | 1994-12-15 |