The following data is part of a premarket notification filed by Silhouette Optical Ltd. with the FDA for Silhouette, Sunlimeted,adidas.
| Device ID | K944160 |
| 510k Number | K944160 |
| Device Name: | SILHOUETTE, SUNLIMETED,ADIDAS |
| Classification | Frame, Spectacle |
| 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 | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-09-28 |