510(k) K893704 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SAFE-1
| Applicant | Polystan C/O Vitalcor, Inc., Denmark, DK |
| Decision | Substantially Equivalent, Dec 22, 1989 |
| Received | May 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893704
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.