The following data is part of a premarket notification filed by Healthtronics with the FDA for Cryocare Cs Surgical System.
| Device ID | K141110 |
| 510k Number | K141110 |
| Device Name: | CRYOCARE CS SURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | HEALTHTRONICS 9825 SPECTRUM DR, BLDG 3 Austin, TX 78717 -4930 |
| Contact | Maritza Ward |
| Correspondent | Maritza Ward HEALTHTRONICS 9825 SPECTRUM DR, BLDG 3 Austin, TX 78717 -4930 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-29 |
| Decision Date | 2015-06-25 |
| Summary: | summary |