K231155
- 510(k) number
- K231155
- Device name
- Biodegradable Medical surgical mask
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd. CN
- Product code
- FXX — Mask, Surgical
- Decision date
- 2023-11-07
- Date received
- 2023-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231155.pdf
Official FDA record: K231155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.