The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Icon Vs General Purpose Rf Generator, Model: Vs300.
| Device ID | K092383 |
| 510k Number | K092383 |
| Device Name: | BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
| Contact | Richard Kozloff |
| Correspondent | Richard Kozloff BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2010-03-10 |
| Summary: | summary |