The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Plasmakinetic Generator.
| Device ID | K003060 |
| 510k Number | K003060 |
| Device Name: | PLASMAKINETIC GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EVEREST MEDICAL CORP. FORTRAN ROAD, St. Mellons, Cardiff, GB Cf3 Olt |
| Contact | David Kay |
| Correspondent | David Kay EVEREST MEDICAL CORP. FORTRAN ROAD, St. Mellons, Cardiff, GB Cf3 Olt |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2000-10-31 |