The following data is part of a premarket notification filed by Elliquence Llc with the FDA for Surgimax/ Surgimax Plus.
| Device ID | K100390 |
| 510k Number | K100390 |
| Device Name: | SURGIMAX/ SURGIMAX PLUS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLIQUENCE LLC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary ELLIQUENCE LLC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-08-25 |
| Summary: | summary |