The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Di-crown.
| Device ID | K812441 |
| 510k Number | K812441 |
| Device Name: | DI-CROWN |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | COBURN OPTICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-26 |
| Decision Date | 1981-10-06 |