510(k) K871350 ยท KRJ Filter, Prebypass, Cardiopulmonary Bypass
PREBYPASS FILTER
| Applicant | American Omni Medical, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Jun 8, 1987 |
| Received | Apr 6, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871350
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.