BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Aurelia Surgical Mask ASTM Level-3 (2130)

    K Number: K242502 · Decision Nov 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    1
    Review Days
    82

    Basic Information

    Device Name
    Aurelia Surgical Mask ASTM Level-3 (2130)
    K Number
    K242502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Supermax Healthcare Canada – Supermax Medical
    Date Received
    August 22, 2024
    Decision Date
    November 12, 2024
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FXX Mask, Surgical

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