The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Calius-isabel Canovas Sunglasses.
| Device ID | K890081 |
| 510k Number | K890081 |
| Device Name: | CALIUS-ISABEL CANOVAS SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Contact | Darienne Moyer |
| Correspondent | Darienne Moyer 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 | 1989-01-10 |
| Decision Date | 1989-03-09 |