510(k) K965214 ยท DTX Gas Control Unit, Cardiopulmonary Bypass
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
| Applicant | Coeur Laboratories, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Dec 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965214
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.