The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Nicolet Cortical Stimulator.
| Device ID | K072964 |
| 510k Number | K072964 |
| Device Name: | NICOLET CORTICAL STIMULATOR |
| Classification | Electrode, Cortical |
| Applicant | CARDINAL HEALTH, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring CARDINAL HEALTH, INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-19 |
| Decision Date | 2008-12-30 |
| Summary: | summary |