510(k) K860539 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SARNS OXYGENATOR SYSTEM
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Apr 29, 1986 |
| Received | Feb 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860539
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.