510(k) K083131 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
MEDOS HILITE RESERVOIR, MODEL: 4030
| Applicant | Gish Biomedical, Inc., Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Jul 30, 2009 |
| Received | Oct 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083131
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.