The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Sterile Subdermal Needle Electrodes.
| Device ID | K010019 |
| 510k Number | K010019 |
| Device Name: | STERILE SUBDERMAL NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| 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 | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-02 |
| Decision Date | 2001-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852373007083 | K010019 | 000 |