The following data is part of a premarket notification filed by Bovie Medical with the FDA for Bovie Icon General Purpose Rf Generator.
| Device ID | K082109 |
| 510k Number | K082109 |
| Device Name: | BOVIE ICON GENERAL PURPOSE RF GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Richard A Kozloff |
| Correspondent | Richard A Kozloff BOVIE MEDICAL 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-25 |
| Decision Date | 2008-10-02 |
| Summary: | summary |