510(k) K812539 ยท KRJ Filter, Prebypass, Cardiopulmonary Bypass
PRE-BYPASS FILTER
| Applicant | Gelman Sciences, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 13, 1981 |
| Received | Sep 3, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812539
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.