510(k) K093069 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Oct 23, 2010 |
| Received | Sep 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093069
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.