The following data is part of a premarket notification filed by Soniquence, Llc with the FDA for Soniquence Rf Generator And Soniquence Electrodes.
| Device ID | K183611 |
| 510k Number | K183611 |
| Device Name: | Soniquence RF Generator And Soniquence Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Soniquence, LLC 2473 Grand Avenue Baldwin, NY 11510 |
| Contact | Suzanne Lucas |
| Correspondent | Suzanne Lucas Soniquence, LLC 2473 Grand Avenue Baldwin, NY 11510 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-05-22 |