510(k) K250459 ยท KPE Container, I.V.
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
| Applicant | Technoflex Sas., Bidart, FR |
| Decision | Substantially Equivalent, Apr 18, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250459
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.