510(k) K082403 ยท DTZ Oxygenator, Cardiopulmonary Bypass
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, May 15, 2009 |
| Received | Aug 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082403
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.