The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Intra-articular Surgical System.
| Device ID | K820367 |
| 510k Number | K820367 |
| Device Name: | INTRA-ARTICULAR SURGICAL SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | DYONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-05-07 |