The following data is part of a premarket notification filed by Bovie Medical with the FDA for Bovie Icon Gi Electrosurgical Generator, Model Gi 120.
| Device ID | K061884 |
| 510k Number | K061884 |
| Device Name: | BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL 3200 TYRONE BLVD., STE. A St. Petersburg, FL 33710 -2902 |
| Contact | Richard Kozloff |
| Correspondent | Richard Kozloff BOVIE MEDICAL 3200 TYRONE BLVD., STE. A 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 | 2006-07-03 |
| Decision Date | 2006-09-06 |
| Summary: | summary |