510(k) K955384 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Portland OR, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Nov 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955384
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.