510(k) K954623 ยท FKT System, Dialysate Delivery, Sorbent Regenerated
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
| Applicant | Gambro Healthcare, Oklahoma City OK, US |
| Decision | Substantially Equivalent, Aug 28, 1996 |
| Received | Oct 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954623
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.