The following data is part of a premarket notification filed by Optical Radiation Corp. with the FDA for 0r 160, Or-1.60, And Orcolite 1.60 High Index.
| Device ID | K920795 |
| 510k Number | K920795 |
| Device Name: | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | OPTICAL RADIATION CORP. 1300 OPTICAL DR. Azusa, CA 91702 |
| Contact | Enid Rokaw |
| Correspondent | Enid Rokaw OPTICAL RADIATION CORP. 1300 OPTICAL DR. Azusa, CA 91702 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-21 |
| Decision Date | 1992-07-13 |