The following data is part of a premarket notification filed by Europa/encore Eyewear with the FDA for Spectacle Frames/sunglasses.
| Device ID | K941051 |
| 510k Number | K941051 |
| Device Name: | SPECTACLE FRAMES/SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EUROPA/ENCORE EYEWEAR 55 E. HINTZ RD. Wheeling, IL 60090 |
| Contact | Jerome J Wolowicz |
| Correspondent | Jerome J Wolowicz EUROPA/ENCORE EYEWEAR 55 E. HINTZ RD. Wheeling, IL 60090 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-03 |
| Decision Date | 1994-04-12 |