510(k) K961465 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
2008H ON LINE CLEARANCE MONITOR
| Applicant | Fresenius USA, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Jul 3, 1997 |
| Received | Apr 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961465
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.