The following data is part of a premarket notification filed by Aristar Inc. U.s.a. with the FDA for Aristar Eyewear, Esprit Eyewear.
| Device ID | K945122 |
| 510k Number | K945122 |
| Device Name: | ARISTAR EYEWEAR, ESPRIT EYEWEAR |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ARISTAR INC. U.S.A. 402 AMERICAN RD. Morris Plains, NJ 07950 -2400 |
| Contact | Mike Otani |
| Correspondent | Mike Otani ARISTAR INC. U.S.A. 402 AMERICAN RD. Morris Plains, NJ 07950 -2400 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-19 |
| Decision Date | 1994-11-22 |