510(k) K201142 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
| Applicant | Simplivia Healthcare , Ltd., Kiryat Shmona, IL |
| Decision | Substantially Equivalent, Feb 25, 2021 |
| Received | Apr 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201142
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.