510(k) K201460 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Closed System Transfer Device
| Applicant | Shinva Ande Healthcare Apparatus Co., Ltd., Zibo, CN |
| Decision | Substantially Equivalent, Nov 23, 2022 |
| Received | Jun 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201460
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.