510(k) K994198 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
| Applicant | Toray Industries (America), Inc., Bellaire TX, US |
| Decision | Substantially Equivalent, Aug 25, 2000 |
| Received | Dec 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994198
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.