The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for G3 Generator And Accessories-dissector Plasma Knife.
| Device ID | K080844 |
| 510k Number | K080844 |
| Device Name: | G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Lorraine Calzetta |
| Correspondent | Lorraine Calzetta GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-26 |
| Decision Date | 2009-08-13 |
| Summary: | summary |