K241988
- 510(k) number
- K241988
- Device name
- ProSeal Closed System Bag Access
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2024-10-23
- Date received
- 2024-07-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241988.pdf
Official FDA record: K241988
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.