510(k) K091062 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
| Applicant | Gish Biomedical, Inc., Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Aug 4, 2009 |
| Received | Apr 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091062
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.