The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Ultimate High Frequency Electrosurgical Generator.
| Device ID | K142975 |
| 510k Number | K142975 |
| Device Name: | Bovie Ultimate High Frequency Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 |
| Contact | Moshe Citronowicz |
| Correspondent | Moshe Citronowicz 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 | 2014-10-14 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607151050122 | K142975 | 000 |
| 10607151010123 | K142975 | 000 |
| 10607151009974 | K142975 | 000 |
| 10607151009769 | K142975 | 000 |