The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Thermogard Dispersive Electrodes, Thermogard Plus Abc Dispersive Electrodes.
| Device ID | K140658 |
| 510k Number | K140658 |
| Device Name: | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Contact | Sandy Leclair |
| Correspondent | Sandy Leclair CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-14 |
| Decision Date | 2014-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405986588 | K140658 | 000 |
| 30845854650138 | K140658 | 000 |
| 20653405007446 | K140658 | 000 |