The following data is part of a premarket notification filed by Synergetics, Inc with the FDA for Stryker Rf Multi-lesion Generator, Model 0406-900-000.
| Device ID | K071482 |
| 510k Number | K071482 |
| Device Name: | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Contact | Dan Regan |
| Correspondent | Dan Regan SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-30 |
| Decision Date | 2007-12-20 |
| Summary: | summary |