510(k) K970654 ยท MSE Hemodialyzer, Re-Use, Low Flux
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Nov 12, 1997 |
| Received | Feb 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970654
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.