The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Altrus Thermal Tissue Fusion System.
| Device ID | K101534 |
| 510k Number | K101534 |
| Device Name: | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORP. 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Shawn Reidel |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-11-24 |
| Summary: | summary |