Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
FDA 510(k) clearance K231005 · decided 2023-12-05
Clearance details
- K-number
- K231005
- Device name
- Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
- Applicant
- Supermax Healthcare Canada-Supermax Medical
- Decision
- Substantially Equivalent
- Date received
- 2023-04-07
- Decision date
- 2023-12-05
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Saint-Bruno-De-Montarville, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.