The following data is part of a premarket notification filed by Frontier Products with the FDA for Ortho-level.
| Device ID | K822305 |
| 510k Number | K822305 |
| Device Name: | ORTHO-LEVEL |
| Classification | Protractor |
| Applicant | FRONTIER PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTH |
| CFR Regulation Number | 888.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-27 |
| Decision Date | 1982-08-20 |