The following data is part of a premarket notification filed by Healthtronics with the FDA for Cryocare Cs-3 Surgical System Version 5.
| Device ID | K151968 |
| 510k Number | K151968 |
| Device Name: | Cryocare CS-3 Surgical System Version 5 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | HEALTHTRONICS 9825 SPECTRUM DRIVE BUILDING 2 Austin, TX 78717 |
| Contact | Scott Eden |
| Correspondent | Maritza Ward HEALTHTRONICS 9825 SPECTRUM DRIVE BUILDING 2 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 | 2015-07-16 |
| Decision Date | 2015-09-09 |
| Summary: | summary |