The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Elmed Thermo-flux.
| Device ID | K952110 |
| 510k Number | K952110 |
| Device Name: | ELMED THERMO-FLUX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Contact | Werner Hausner |
| Correspondent | Werner Hausner ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-05 |
| Decision Date | 1995-08-14 |