510(k) K813255 ยท DTZ Oxygenator, Cardiopulmonary Bypass
LPM/50 MEMBRANE OXYGENATOR
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 18, 1982 |
| Received | Nov 19, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813255
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.