The following data is part of a premarket notification filed by Health Tronics with the FDA for Cryocare Cs Surgical System.
| Device ID | K153489 |
| 510k Number | K153489 |
| Device Name: | Cryocare CS Surgical System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Health Tronics 9825 Spectrum Dr. Austin, TX 78717 |
| Contact | Maritza Ward |
| Correspondent | Maritza Ward Health Tronics 9825 Spectrum Dr. Austin, TX 78717 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-04 |
| Decision Date | 2016-02-05 |
| Summary: | summary |