The following data is part of a premarket notification filed by Bacou Usa, Inc. And Uvex Safety, Inc. with the FDA for Sun/sportglasses.
| Device ID | K920211 |
| 510k Number | K920211 |
| Device Name: | SUN/SPORTGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | BACOU USA, INC. AND UVEX SAFETY, INC. 10 THURBER BLVD. Smithfield, RI 02917 -1896 |
| Contact | Steven P Tolisano |
| Correspondent | Steven P Tolisano BACOU USA, INC. AND UVEX SAFETY, INC. 10 THURBER BLVD. Smithfield, RI 02917 -1896 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-16 |
| Decision Date | 1992-05-01 |