510(k) K962309 ยท FJI Dialyzer, Capillary, Hollow Fiber
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Miami Lakes FL, US |
| Decision | Substantially Equivalent, Dec 27, 1996 |
| Received | Jun 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962309
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.