The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie J-plasma Handpiece With Retractable Cutting Blade.
| Device ID | K112233 |
| 510k Number | K112233 |
| Device Name: | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
| Contact | Richard A Kozloff |
| Correspondent | Richard A 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 | 2011-08-04 |
| Decision Date | 2012-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607151009455 | K112233 | 000 |
| 10607151007819 | K112233 | 000 |
| 10607151007604 | K112233 | 000 |