K231005
- 510(k) number
- K231005
- Device name
- Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
- Applicant
- Supermax Healthcare Canada-Supermax Medical CA
- Product code
- FXX — Mask, Surgical
- Decision date
- 2023-12-05
- Date received
- 2023-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K231005.pdf
Official FDA record: K231005
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.