The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Cautery; Low Temperature (fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip).
| Device ID | K121441 |
| 510k Number | K121441 |
| Device Name: | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) |
| Classification | Unit, Cautery, Thermal, Battery-powered |
| 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 | HQP |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2012-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040007317 | K121441 | 000 |
| 50885380001459 | K121441 | 000 |
| 50885380001473 | K121441 | 000 |
| 50885380001480 | K121441 | 000 |
| 50885380001763 | K121441 | 000 |
| 10607151008953 | K121441 | 000 |
| 00607151008963 | K121441 | 000 |
| 00607151008970 | K121441 | 000 |
| 10607151008984 | K121441 | 000 |
| 00607151011017 | K121441 | 000 |
| 10607151011038 | K121441 | 000 |
| 10607151011052 | K121441 | 000 |
| 10607151011212 | K121441 | 000 |
| 10304040007294 | K121441 | 000 |
| 10304040007300 | K121441 | 000 |
| 50885380001442 | K121441 | 000 |