510(k) K990103 ยท DTZ Oxygenator, Cardiopulmonary Bypass
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
| Applicant | Sorin Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 5, 1999 |
| Received | Jan 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990103
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.