The following data is part of a premarket notification filed by Thermigen, L.l.c with the FDA for Thermix Temperature Control Radiofrequency System, Accessories - Rf Electrodes.
| Device ID | K173582 |
| 510k Number | K173582 |
| Device Name: | ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ThermiGen, L.L.C 3131 West Royal Lane, Suite 100 Irving, TX 75063 |
| Contact | Suzanne Cheang |
| Correspondent | Suzanne Cheang ThermiGen, L.L.C 3131 West Royal Lane, Suite 100 Irving, TX 75063 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817371020359 | K173582 | 000 |
| 00817771028979 | K173582 | 000 |
| 00817771028986 | K173582 | 000 |
| 00817771028993 | K173582 | 000 |
| 00817771029020 | K173582 | 000 |
| 00817771029037 | K173582 | 000 |
| 00817771029099 | K173582 | 000 |
| 00817771029105 | K173582 | 000 |
| 00817771029112 | K173582 | 000 |
| 00817771029129 | K173582 | 000 |
| 00817371020618 | K173582 | 000 |
| 00817771028962 | K173582 | 000 |