The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Subdural Strip Electrode.
| Device ID | K021144 |
| 510k Number | K021144 |
| Device Name: | SUBDURAL STRIP ELECTRODE |
| Classification | Electrode, Cortical |
| Applicant | NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. 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 | 2002-04-09 |
| Decision Date | 2002-06-24 |
| Summary: | summary |