510(k) K123395 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Mar 7, 2013 |
| Received | Nov 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123395
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.