The following data is part of a premarket notification filed by Thermigen, Inc. with the FDA for Symphony Rf Generator.
| Device ID | K130689 |
| 510k Number | K130689 |
| Device Name: | SYMPHONY RF GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THERMIGEN, INC. 401 N. CARROLL AVE Southlake, TX 76092 |
| Contact | Kevin O'brien |
| Correspondent | Kevin O'brien THERMIGEN, INC. 401 N. CARROLL AVE Southlake, TX 76092 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817371020069 | K130689 | 000 |
| 00817771029051 | K130689 | 000 |
| 00817771029068 | K130689 | 000 |
| 00817771029075 | K130689 | 000 |
| 00817771029136 | K130689 | 000 |
| 00817771029143 | K130689 | 000 |
| 00817771029150 | K130689 | 000 |
| 00817771029167 | K130689 | 000 |
| 00817771029181 | K130689 | 000 |
| 00817771029273 | K130689 | 000 |
| 00817371020014 | K130689 | 000 |
| 00817371020021 | K130689 | 000 |
| 00817371020038 | K130689 | 000 |
| 00817371020045 | K130689 | 000 |
| 00817371020052 | K130689 | 000 |
| 00817771029044 | K130689 | 000 |