K232797
- 510(k) number
- K232797
- Device name
- Hygenix
- Applicant
- Shenzhen Hygenix Industrial Co., Ltd. CN
- Product code
- FXX — Mask, Surgical
- Decision date
- 2023-12-11
- Date received
- 2023-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232797.pdf
Official FDA record: K232797
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.