510(k) K251340 · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ProSeal Bag Spike with Additive Port (423370ST, 423370)
| Applicant | Epic Medical Pte. , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, May 29, 2025 |
| Received | Apr 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251340
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.