The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator.
| Device ID | K134054 |
| 510k Number | K134054 |
| Device Name: | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL CORPORATION 5115 ULMERTON ROAD Clearwater, FL 33760 -4004 |
| Contact | Richard A Kozloff |
| Correspondent | Richard A Kozloff BOVIE MEDICAL CORPORATION 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 | 2013-12-31 |
| Decision Date | 2014-03-17 |
| Summary: | summary |