510(k) K032794 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
CUSTODIOL
| Applicant | Dr. Franz Kohler Chemie GmbH, Brookeville MD, US |
| Decision | Substantially Equivalent, Apr 5, 2004 |
| Received | Sep 8, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032794
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.