The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Spectacles Lens.
| Device ID | K860955 |
| 510k Number | K860955 |
| Device Name: | SPECTACLES LENS |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| 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 | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-13 |
| Decision Date | 1986-03-31 |