510(k) K944492 ยท LIF Dialyzer Reprocessing System
DIALYZER REPROCESSING SYSTEM
| Applicant | G.E.M. Water Systems, Cypress CA, US |
| Decision | Substantially Equivalent, Aug 28, 1995 |
| Received | Sep 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944492
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.