510(k) K121161 ยท KPE Container, I.V.
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
| Applicant | Acta Medical, LLC, Plano TX, US |
| Decision | Substantially Equivalent, Jul 13, 2012 |
| Received | Apr 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121161
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.