510(k) K833253 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SHILEY M2000 MEMBRANE OXYGENATOR
| Applicant | Shiley, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 1, 1983 |
| Received | Sep 20, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833253
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.