The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Plasmakinetic (pk) Superpulse System, Model 744000 And Dual Footswitch Connector Cable, Model 710003.
| Device ID | K082054 |
| 510k Number | K082054 |
| Device Name: | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence E Sullivan |
| Correspondent | Terrence E Sullivan GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2008-08-06 |
| Summary: | summary |