510(k) K050952 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
| Applicant | Minntech Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 31, 2006 |
| Received | Apr 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050952
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.