The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Dyonics Disposable Arthroscopic Surgery Blades Modification.
| Device ID | K934299 |
| 510k Number | K934299 |
| Device Name: | DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Cesidio Tempesta |
| Correspondent | Cesidio Tempesta SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-02 |
| Decision Date | 1994-02-14 |