The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion System.
| Device ID | K140459 |
| 510k Number | K140459 |
| Device Name: | ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Contact | Lisa Anderson |
| Correspondent | Lisa Anderson 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 | 2014-02-24 |
| Decision Date | 2014-07-11 |
| Summary: | summary |