K812441 is an FDA 510(k) clearance for the DI-CROWN. This device is classified as a Lens, Spectacle, Non-custom (prescription) (Class I - General Controls, product code HQG).
Submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981, 41 days after receiving the submission on August 26, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5844.
| 510(k) Number | K812441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1981 |
| Decision Date | October 06, 1981 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQG — Lens, Spectacle, Non-custom (prescription) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5844 |