The following data is part of a premarket notification filed by Colorado Biomedical, Inc. with the FDA for Colorado Needle Electrode.
| Device ID | K881763 |
| 510k Number | K881763 |
| Device Name: | COLORADO NEEDLE ELECTRODE |
| Classification | Electrode, Electrosurgical |
| Applicant | COLORADO BIOMEDICAL, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Contact | Newkirk, Dsc |
| Correspondent | Newkirk, Dsc COLORADO BIOMEDICAL, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-25 |
| Decision Date | 1988-06-20 |