The following data is part of a premarket notification filed by Bovie Medical with the FDA for Bovie Icon Gs Electrosurgical Generator (gs100), Handpiece (gs-op-r), Reusable Handpiece Cable (gs807-rc).
| Device ID | K090586 |
| 510k Number | K090586 |
| Device Name: | BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL 5115 ULMERTON ROAD Clearwater, FL 33760 -4004 |
| Contact | Richard A Kozloff |
| Correspondent | Richard A Kozloff BOVIE MEDICAL 5115 ULMERTON ROAD Clearwater, FL 33760 -4004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-04 |
| Decision Date | 2009-08-07 |
| Summary: | summary |