510(k) K012510 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Oct 19, 2001 |
| Received | Aug 6, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012510
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.