K233037
- 510(k) number
- K233037
- Device name
- Sterile Hypodermic Needles for Single Use
- Applicant
- Zhejiang Kindly Medical Device Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2023-12-12
- Date received
- 2023-09-25
- 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: K233037.pdf
Official FDA record: K233037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.