The following data is part of a premarket notification filed by Bovie Medical with the FDA for Boss Coagulation Device, Model Boss1215, Boss Coagulation Device, Angled Access, Model Bosa1215.
| Device ID | K092149 |
| 510k Number | K092149 |
| Device Name: | BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL 5115 ULMERTON ROAD Clearwater, FL 33760 -4004 |
| Contact | Richard Kozloff |
| Correspondent | Richard 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 | 2009-07-16 |
| Decision Date | 2010-03-18 |
| Summary: | summary |