The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Dyonics Disposable Endoscopic Surgery Blades.
| Device ID | K954989 |
| 510k Number | K954989 |
| Device Name: | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Deborah J Connors |
| Correspondent | Deborah J Connors SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-31 |
| Decision Date | 1995-11-27 |