The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Bantam/pro Electrosurgical Generator, Bovie Derm 941 Electrosurgical Generator, Bovie Derm 942 Electrosurgical Generator.
| Device ID | K161134 |
| 510k Number | K161134 |
| Device Name: | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL CORPORATION 5115 ULMERTON ROAD Clearwater, FL 33760 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst 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 | 2016-04-22 |
| Decision Date | 2016-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040041451 | K161134 | 000 |
| 00304040041444 | K161134 | 000 |
| 00607151011185 | K161134 | 000 |
| 00607151011178 | K161134 | 000 |
| 00607151011161 | K161134 | 000 |
| 20612479212941 | K161134 | 000 |