510(k) K964922 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Portland OR, US |
| Decision | Substantially Equivalent, May 21, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964922
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.