K231363
- 510(k) number
- K231363
- Device name
- Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- Applicant
- Hantech Medical Device Co., Ltd. CN
- Product code
- NGT — Saline, Vascular Access Flush
- Decision date
- 2023-09-27
- Date received
- 2023-05-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231363.pdf
Official FDA record: K231363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.