K935919 is an FDA 510(k) clearance for the SUNGLASSES. This device is classified as a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG).
Submitted by Ja-Ru, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 16, 1994, 70 days after receiving the submission on December 8, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5844.
| 510(k) Number | K935919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1993 |
| Decision Date | February 16, 1994 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQG — Lens, Spectacle, Non-custom (prescription) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.5844 |