510(k) K945624 ยท FJI Dialyzer, Capillary, Hollow Fiber
MCA(TM) 160 HEMODIALYZER
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Miami Lakes FL, US |
| Decision | Substantially Equivalent, May 18, 1995 |
| Received | Nov 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945624
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.