Aurelia Surgical Mask ASTM Level-3 (2130)— 510(k) K242502
Substantially EquivalentSupermax Healthcare Canada Supermax Medical
FDA 510(k) clearance K242502 for Aurelia Surgical Mask ASTM Level-3 (2130), Substantially Equivalent on 2024-11-12. Applicant: Supermax Healthcare Canada Supermax Medical.
Clearance details
- Applicant
- Supermax Healthcare Canada Supermax Medical
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint-Bruno-De-Montarville, CA
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.