The following data is part of a premarket notification filed by Bovie Medical Corp. with the FDA for Freezpoint.
| Device ID | K180211 |
| 510k Number | K180211 |
| Device Name: | Freezpoint |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Bovie Medical Corp. 5115 Ulmerton Road Clearwater, FL 33760 |
| Contact | Sam Niedbala |
| Correspondent | Sam Niedbala CryoConcepts LP 205 Webster Street Bethlehem, PA 18015 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-03-21 |
| Summary: | summary |