510(k) K803231 ยท DTZ Oxygenator, Cardiopulmonary Bypass
THB 6000 HARDSHELL BUBBLE OXYGENATOR
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 16, 1981 |
| Received | Dec 22, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803231
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.