510(k) K160591 ยท HRN Unit, Cryophthalmic, Ac-Powered
D.O.R.C. Disposable Cryo Probe
| Applicant | Dutch Ophthalmic Research Center International BV, Zuidland, NL |
| Decision | Substantially Equivalent, Jan 23, 2017 |
| Received | Mar 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160591
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.