510(k) K002512 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
TORAYSULFONE DIALYZER
| Applicant | Toray Industries (America), Inc., Bellaire TX, US |
| Decision | Substantially Equivalent, Oct 15, 2001 |
| Received | Aug 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002512
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2004 | Toray Marketing & Sales (America), Inc Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8 Terminated |
FJI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.