K230343
- 510(k) number
- K230343
- Device name
- ProSeal Closed System Administration Set
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2023-11-03
- Date received
- 2023-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230343.pdf
Official FDA record: K230343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.