The following data is part of a premarket notification filed by Bacou Usa, Inc. And Uvex Safety, Inc. with the FDA for Uvex Alpha, Beta, Gamma & Delta Sun.
| Device ID | K820016 |
| 510k Number | K820016 |
| Device Name: | UVEX ALPHA, BETA, GAMMA & DELTA SUN |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | BACOU USA, INC. AND UVEX SAFETY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-05 |
| Decision Date | 1982-03-19 |