510(k) K952342 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
| Applicant | Cobe Renal Care, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 15, 1995 |
| Received | May 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952342
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.