The following data is part of a premarket notification filed by Optikos Shami, Inc. with the FDA for Optikos Shami, Inc. Sunglasses.
| Device ID | K934197 |
| 510k Number | K934197 |
| Device Name: | OPTIKOS SHAMI, INC. SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | OPTIKOS SHAMI, INC. 15375 BARRANCA PKWY. STE. G106 Irvine, CA 92718 |
| Contact | Ray Bilbessi |
| Correspondent | Ray Bilbessi OPTIKOS SHAMI, INC. 15375 BARRANCA PKWY. STE. G106 Irvine, CA 92718 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1994-01-25 |