510(k) K163485 ยท CAF Nebulizer (Direct Patient Interface)
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| Applicant | Adherium (Nz), Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Aug 30, 2017 |
| Received | Dec 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163485
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.