The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating And Non-aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-aspirating.
| Device ID | K161558 |
| 510k Number | K161558 |
| Device Name: | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating And Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL CORPORATION 5115 ULMERTON ROAD Clearwater, FL 33760 |
| Contact | Rubiela Maldonado |
| Correspondent | Rubiela Maldonado BOVIE MEDICAL CORPORATION 5115 ULMERTON ROAD Clearwater, FL 33760 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2016-07-29 |
| Summary: | summary |