510(k) K823533 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
JACKET & SET
| Applicant | Shiley, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 30, 1982 |
| Received | Nov 29, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823533
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.