510(k) K190459 ยท FJI Dialyzer, Capillary, Hollow Fiber
Hemoflow F3 and F4 Dialyzers
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | Feb 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190459
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.