The following data is part of a premarket notification filed by Mistral Optical with the FDA for Mistral Sunglasses.
| Device ID | K960668 |
| 510k Number | K960668 |
| Device Name: | MISTRAL SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | MISTRAL OPTICAL VIA DEL FAGHER ZONA ARTIGIANALE Quero Belluno, IT 32030 |
| Contact | Stramare Angelo |
| Correspondent | Stramare Angelo MISTRAL OPTICAL VIA DEL FAGHER ZONA ARTIGIANALE Quero Belluno, IT 32030 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-20 |
| Decision Date | 1996-05-31 |