510(k) K113023 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Dec 21, 2012 |
| Received | Oct 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113023
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.