K242502
- 510(k) number
- K242502
- Device name
- Aurelia Surgical Mask ASTM Level-3 (2130)
- Applicant
- Supermax Healthcare Canada Supermax Medical CA
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-11-12
- Date received
- 2024-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K242502.pdf
Official FDA record: K242502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.