K232359
- 510(k) number
- K232359
- Device name
- Surgical face mask
- Applicant
- Kingstar Medical (Xianning) Co., Ltd. CN
- Product code
- FXX — Mask, Surgical
- Decision date
- 2023-10-02
- Date received
- 2023-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232359.pdf
Official FDA record: K232359
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.