The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Resistick Ii Coated Electrosurgical Electrodes.
| Device ID | K093025 |
| 510k Number | K093025 |
| Device Name: | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
| Contact | Richard Kozloff |
| Correspondent | Richard Kozloff BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2009-12-22 |
| Summary: | summary |