510(k) K043342 ยท FJI Dialyzer, Capillary, Hollow Fiber
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, May 27, 2005 |
| Received | Dec 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043342
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.