510(k) K013038 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
| Applicant | Polystan A/S, Vaerlose, DK |
| Decision | Substantially Equivalent, Aug 14, 2002 |
| Received | Sep 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013038
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.