510(k) K973516 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
CAPIOX HEMOCONCENTRATOR
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jan 30, 1998 |
| Received | Sep 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973516
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.