The following data is part of a premarket notification filed by Thermi with the FDA for Thermi Rf Accessories.
| Device ID | K161661 |
| 510k Number | K161661 |
| Device Name: | Thermi RF Accessories |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THERMI 8304 ESTERS BLVD STE 890 Irving, TX 75063 |
| Contact | Carrie Eddings |
| Correspondent | Carrie Eddings THERMI 8304 ESTERS BLVD STE 890 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 | 2016-06-16 |
| Decision Date | 2016-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817771029006 | K161661 | 000 |