The following data is part of a premarket notification filed by Cosmas Optical Usa Ltd. with the FDA for Spectacle Frames.
| Device ID | K841908 |
| 510k Number | K841908 |
| Device Name: | SPECTACLE FRAMES |
| Classification | Frame, Spectacle |
| Applicant | COSMAS OPTICAL USA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-08 |
| Decision Date | 1984-06-07 |