510(k) K850139 ยท KRJ Filter, Prebypass, Cardiopulmonary Bypass
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER
| Applicant | Rapid Diagnostic Laboratories, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Apr 10, 1985 |
| Received | Jan 14, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850139
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.