510(k) K953976 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SAFE MICRO
| Applicant | Polystan A/S, Vaerlose, DK |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Aug 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953976
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.