510(k) K945746 ยท FJI Dialyzer, Capillary, Hollow Fiber
GAMBRO LUNDIA 94-500 DIALYZER
| Applicant | Cobe Renal Care, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 8, 1995 |
| Received | Nov 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945746
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.