The following data is part of a premarket notification filed by Janlin Ent. with the FDA for Visor Sunglasses/lens/novelty Visor.
| Device ID | K915266 |
| 510k Number | K915266 |
| Device Name: | VISOR SUNGLASSES/LENS/NOVELTY VISOR |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | JANLIN ENT. 4001 PACIFIC COAST HIGHWAY SUITE 408 Torrance, CA 90505 |
| Contact | Janet L Tighe |
| Correspondent | Janet L Tighe JANLIN ENT. 4001 PACIFIC COAST HIGHWAY SUITE 408 Torrance, CA 90505 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-20 |
| Decision Date | 1992-09-02 |