The following data is part of a premarket notification filed by Soniquence, Llc with the FDA for Soniquence Reusable Bipolar Cable.
| Device ID | K211946 |
| 510k Number | K211946 |
| Device Name: | Soniquence Reusable Bipolar Cable |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 |
| Contact | Suzanne Lucas |
| Correspondent | Suzanne Lucas Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-23 |
| Decision Date | 2021-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810026180514 | K211946 | 000 |
| 00810026180507 | K211946 | 000 |