510(k) K162695 ยท GEH Unit, Cryosurgical, Accessories
truFreeze System
| Applicant | CSA Medical, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Oct 25, 2016 |
| Received | Sep 27, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162695
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.