510(k) K912078 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Aug 20, 1991 |
| Received | May 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912078
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.