The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Dyonics Arthroscopic Kit.
| Device ID | K920267 |
| 510k Number | K920267 |
| Device Name: | DYONICS ARTHROSCOPIC KIT |
| Classification | General Surgery Tray |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Jeffrey Greeen |
| Correspondent | Jeffrey Greeen SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-21 |
| Decision Date | 1993-03-23 |