510(k) K823343 ยท DTZ Oxygenator, Cardiopulmonary Bypass
OXYGENATOR 10
| Applicant | Gambro, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 15, 1982 |
| Received | Nov 8, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823343
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.