The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Disposable Arthroscopy Blade.
| Device ID | K833587 |
| 510k Number | K833587 |
| Device Name: | DISPOSABLE ARTHROSCOPY BLADE |
| Classification | Arthroscope |
| Applicant | DYONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-12 |
| Decision Date | 1983-11-14 |