The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi General Surgery Workstation, Model G400, And Dual Footswitch Connector Cable.
| Device ID | K081954 |
| 510k Number | K081954 |
| Device Name: | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE |
| 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 | 2008-07-09 |
| Decision Date | 2008-07-31 |
| Summary: | summary |