The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Neuro N100 Radiofrequency Generator And Accessory Cables.
| Device ID | K010969 |
| 510k Number | K010969 |
| Device Name: | NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-04-20 |