510(k) K970650 ยท MSE Hemodialyzer, Re-Use, Low Flux
ASAHI AM-R SERIES DIALYZERS
| Applicant | Asahi Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Sep 30, 1997 |
| Received | Feb 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970650
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.