510(k) K253033 · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
| Applicant | Simplivia Healthcare , Ltd., Kiryat Shmona, IL |
| Decision | Substantially Equivalent, Oct 21, 2025 |
| Received | Sep 22, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253033
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.