The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Vision 325z Dv3-ccd Hermes Ready Camera System, Model 7209531.
| Device ID | K031379 |
| 510k Number | K031379 |
| Device Name: | DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-01 |
| Decision Date | 2003-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554013504 | K031379 | 000 |
| 00885554013047 | K031379 | 000 |
| 03596010542205 | K031379 | 000 |
| 03596010542199 | K031379 | 000 |
| 03596010539359 | K031379 | 000 |
| 03596010539342 | K031379 | 000 |
| 03596010601193 | K031379 | 000 |