The following data is part of a premarket notification filed by Eyeworks 3 with the FDA for Theo Non-prescription Sunglasses/spectacle Frames.
| Device ID | K924938 |
| 510k Number | K924938 |
| Device Name: | THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EYEWORKS 3 7408 BEVERLY BLVD. Los Angeles, CA 90036 |
| Contact | David P Duralde |
| Correspondent | David P Duralde EYEWORKS 3 7408 BEVERLY BLVD. Los Angeles, CA 90036 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-04-06 |