The following data is part of a premarket notification filed by Optique Forte Ltd. with the FDA for Opthalmic Frames.
| Device ID | K922687 |
| 510k Number | K922687 |
| Device Name: | OPTHALMIC FRAMES |
| Classification | Frame, Spectacle |
| Applicant | OPTIQUE FORTE LTD. 17 ST. JOSEPH ST. SUITE 209 Toronto, Ontario, CA M4y 1j8 |
| Contact | George Kux |
| Correspondent | George Kux OPTIQUE FORTE LTD. 17 ST. JOSEPH ST. SUITE 209 Toronto, Ontario, CA M4y 1j8 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1992-08-31 |