The following data is part of a premarket notification filed by Thermosurgery Technologies, Inc. with the FDA for Thermomed 1.8.
| Device ID | K063748 |
| 510k Number | K063748 |
| Device Name: | THERMOMED 1.8 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THERMOSURGERY TECHNOLOGIES, INC. 2901 W. INDIAN SCHOOL RD. Phoenix, AZ 85017 -4162 |
| Contact | Gene Zischke |
| Correspondent | Gene Zischke THERMOSURGERY TECHNOLOGIES, INC. 2901 W. INDIAN SCHOOL RD. Phoenix, AZ 85017 -4162 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-02-01 |
| Summary: | summary |