510(k) K001283 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
LIFEMATE HEMOFILTRATION SYSTEM
| Applicant | Nxstage Medical, Inc., Tewksburt MA, US |
| Decision | Substantially Equivalent, Jan 17, 2001 |
| Received | Apr 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001283
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.