510(k) K862068 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
| Applicant | Gelman Sciences, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Aug 8, 1986 |
| Received | May 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862068
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.