510(k) K812660 ยท DTZ Oxygenator, Cardiopulmonary Bypass
TERUMO HOLLOW FIBER OXYGENATOR
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Dec 14, 1981 |
| Received | Sep 18, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812660
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.