K890081 is an FDA 510(k) clearance for the CALIUS-ISABEL CANOVAS SUNGLASSES. This device is classified as a Sunglasses (non-prescription Including Photosensitive) (Class I — General Controls, product code HQY).
Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on March 9, 1989, 58 days after receiving the submission on January 10, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5850.
| 510(k) Number | K890081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1989 |
| Decision Date | March 09, 1989 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQY — Sunglasses (non-prescription Including Photosensitive) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.5850 |