The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Sunglasses (non-prescription).
| Device ID | K860953 |
| 510k Number | K860953 |
| Device Name: | SUNGLASSES (NON-PRESCRIPTION) |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Contact | Antoine Chambord |
| Correspondent | Antoine Chambord ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-13 |
| Decision Date | 1986-10-24 |