The following data is part of a premarket notification filed by Elliquence, Llc with the FDA for Surgi Max Ultra.
| Device ID | K170107 |
| 510k Number | K170107 |
| Device Name: | Surgi Max Ultra |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | elliquence, LLC 2455 Grand Avenue Baldwin, NY 11510 |
| Contact | Paul D. Buhrke Iv |
| Correspondent | Paul D. Buhrke Iv elliquence, LLC 2455 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 | 2017-01-12 |
| Decision Date | 2017-05-03 |
| Summary: | summary |