510(k) K161835 ยท GXH Device, Surgical, Cryogenic
iovera system
| Applicant | Myoscience, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Jul 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161835
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.