K230043
- 510(k) number
- K230043
- Device name
- Insulin Pen Needle
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2023-09-20
- Date received
- 2023-01-06
- 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: K230043.pdf
Official FDA record: K230043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.