The following data is part of a premarket notification filed by Pan Oceanic Eyewear with the FDA for Spectacle Frames And Sunglasses.
| Device ID | K935974 |
| 510k Number | K935974 |
| Device Name: | SPECTACLE FRAMES AND SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | PAN OCEANIC EYEWEAR 15 WEST 37 ST. New York, NY 10018 |
| Contact | Leo Esses |
| Correspondent | Leo Esses PAN OCEANIC EYEWEAR 15 WEST 37 ST. New York, NY 10018 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-04-06 |