510(k) K161337 ยท GEH Unit, Cryosurgical, Accessories
CryoDose H or Similar
| Applicant | Nuance Medical, LLC, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 12, 2016 |
| Received | May 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161337
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.