The following data is part of a premarket notification filed by Visard Srl with the FDA for Visard Sunglasses.
| Device ID | K961117 |
| 510k Number | K961117 |
| Device Name: | VISARD SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | VISARD SRL VIA FELTRINA, 18 32030 QUERO Belluno, IT |
| Contact | Stramare Angelo |
| Correspondent | Stramare Angelo VISARD SRL VIA FELTRINA, 18 32030 QUERO Belluno, IT |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-20 |
| Decision Date | 1996-04-24 |