510(k) K935471 ยท FJI Dialyzer, Capillary, Hollow Fiber
FILTRYZER(TM)
| Applicant | Toray Industries (America), Inc., Otsu-Shi, Shiga-Ken 520, JP |
| Decision | Substantially Equivalent, May 19, 1995 |
| Received | Nov 15, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2004 | Toray Marketing & Sales (America), Inc Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H Terminated |
FJI | None listed |
| Jan 14, 2004 | Toray Marketing & Sales (America), Inc Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU Terminated |
FJI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.