The following data is part of a premarket notification filed by Omni Scientific, Inc. with the FDA for Knee Brace/stabilizer.
| Device ID | K802673 |
| 510k Number | K802673 |
| Device Name: | KNEE BRACE/STABILIZER |
| Classification | Joint, Knee, External Brace |
| Applicant | OMNI SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITQ |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-27 |
| Decision Date | 1980-11-12 |