510(k) K970674 ยท FIN Tank, Holding, Dialysis
G.E.M. WATER SYSTEMS, INTERNATIONAL
| Applicant | G.E.M. Water Systems, Cypress CA, US |
| Decision | Substantially Equivalent, Nov 19, 1997 |
| Received | Feb 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970674
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.