The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie J-plasma Precise Open Handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator.
| Device ID | K170188 |
| 510k Number | K170188 |
| Device Name: | Bovie J-Plasma Precise Open Handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator |
| 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 | 2017-01-23 |
| Decision Date | 2017-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607151011922 | K170188 | 000 |
| 10607151011915 | K170188 | 000 |
| 10607151011878 | K170188 | 000 |
| 10607151011861 | K170188 | 000 |
| 00607151050139 | K170188 | 000 |