510(k) K953996 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
| Applicant | NIKKISO CO., LTD., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Aug 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953996
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.