510(k) K061519 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
| Applicant | NIKKISO CO., LTD., Tokyo, JP |
| Decision | Substantially Equivalent, Sep 28, 2007 |
| Received | Jun 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061519
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.