510(k) K192075 · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ProSeal Closed System drug Transfer Device (CSTD)
| Applicant | Epic Medical Pte. , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Aug 7, 2020 |
| Received | Aug 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192075
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.