The following data is part of a premarket notification filed by M.y. Vision Corp. with the FDA for Spectacle Frame.
| Device ID | K945323 |
| 510k Number | K945323 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | M.Y. VISION CORP. 91A PROSPECT ST. Paramus, NJ 07652 |
| Contact | David Chung |
| Correspondent | David Chung M.Y. VISION CORP. 91A PROSPECT ST. Paramus, NJ 07652 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1994-11-22 |