The following data is part of a premarket notification filed by Bacou Usa, Inc. And Uvex Safety, Inc. with the FDA for Uvex Mini-specs.
| Device ID | K813548 |
| 510k Number | K813548 |
| Device Name: | UVEX MINI-SPECS |
| Classification | Spectacle, Magnifying |
| Applicant | BACOU USA, INC. AND UVEX SAFETY, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | HOI |
| CFR Regulation Number | 886.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-21 |
| Decision Date | 1982-03-02 |