510(k) K991512 ยท FJI Dialyzer, Capillary, Hollow Fiber
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
| Applicant | Asahi Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Jul 29, 1999 |
| Received | Apr 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991512
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene blo Terminated |
FJI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.