510(k) K911603 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HEMOSPAL KIT B22
| Applicant | C.G.H. Medical, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Aug 7, 1991 |
| Received | Apr 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911603
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.