K231856
- 510(k) number
- K231856
- Device name
- TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
- Applicant
- Medexel Co.,Ltd KR
- Product code
- QNQ — Low Dead Space Piston Syringe
- Decision date
- 2024-03-15
- Date received
- 2023-06-23
- 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: K231856.pdf
Official FDA record: K231856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.