The following data is part of a premarket notification filed by Silhouette Optical Ltd. with the FDA for Silhouette Sunlimited Adidas.
| Device ID | K950519 |
| 510k Number | K950519 |
| Device Name: | SILHOUETTE SUNLIMITED ADIDAS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SILHOUETTE OPTICAL LTD. 266 UNION ST. Northvale, NJ 07647 |
| Contact | W. Huber |
| Correspondent | W. Huber SILHOUETTE OPTICAL LTD. 266 UNION ST. Northvale, NJ 07647 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-03-02 |