510(k) K163400 ยท KZH Introducer, Syringe Needle
Orbit Inserter
| Applicant | Ypsomed AG, Burgdorf, CH |
| Decision | Substantially Equivalent, Jul 26, 2017 |
| Received | Dec 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163400
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.