The following data is part of a premarket notification filed by Eyemart Express, Inc. with the FDA for Spectacle Frames.
| Device ID | K941307 |
| 510k Number | K941307 |
| Device Name: | SPECTACLE FRAMES |
| Classification | Frame, Spectacle |
| Applicant | EYEMART EXPRESS, INC. 1325 CAPITAL CENTER PKWY. SUITE 130 Carrollton, TX 75006 |
| Contact | Debra Weber |
| Correspondent | Debra Weber EYEMART EXPRESS, INC. 1325 CAPITAL CENTER PKWY. SUITE 130 Carrollton, TX 75006 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1994-05-17 |