The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Conmed Macrolyte Dispersive Electrode.
| Device ID | K100686 |
| 510k Number | K100686 |
| Device Name: | CONMED MACROLYTE DISPERSIVE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Shawn Riedel |
| Correspondent | Shawn Riedel CONMED CORPORATION 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-05-21 |