510(k) K193542 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
| Applicant | Bellco Srl, Mirandola, IT |
| Decision | Substantially Equivalent, Oct 8, 2020 |
| Received | Dec 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193542
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.