K253033
- 510(k) number
- K253033
- Device name
- Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
- Applicant
- Simplivia Healthcare , Ltd. IL
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2025-10-21
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253033.pdf
Official FDA record: K253033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.