510(k) K160881 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Nov 15, 2016 |
| Received | Mar 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160881
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.