The following data is part of a premarket notification filed by Modo Eyewear Usa with the FDA for Sunglasses.
| Device ID | K941786 |
| 510k Number | K941786 |
| Device Name: | SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | MODO EYEWEAR USA 594 BROADWAY New York, NY 10012 |
| Contact | Alessandro Lanaro |
| Correspondent | Alessandro Lanaro MODO EYEWEAR USA 594 BROADWAY New York, NY 10012 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-11 |
| Decision Date | 1994-05-17 |