510(k) K192866 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Chemfort CSTD
| Applicant | Simplivia Healthcare , Ltd., Kiryat Shmona, IL |
| Decision | Substantially Equivalent, May 7, 2020 |
| Received | Oct 7, 2019 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K192866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2022 | SIMPLIVIA HEALTHCARE LTD. OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 Open, Classified |
ONB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.