K251411
- 510(k) number
- K251411
- Device name
- Chemfort Female Luer Lock Adaptor
- Applicant
- Simplivia Healthcare , Ltd. IL
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2025-08-05
- Date received
- 2025-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251411.pdf
Official FDA record: K251411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.