The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Disposable Endoscopic Surgery Blades.
| Device ID | K970511 |
| 510k Number | K970511 |
| Device Name: | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Deborah J Connors |
| Correspondent | Deborah J Connors SMITH & NEPHEW, 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 | 1997-02-11 |
| Decision Date | 1997-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885554009136 | K970511 | 000 |
| 23596010477891 | K970511 | 000 |
| 23596010408383 | K970511 | 000 |