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

    PRIMED Surgical Masks and PRIMED Procedure Masks

    K Number: K240286 · Decision Aug 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    1
    Review Days
    207

    Basic Information

    Device Name
    PRIMED Surgical Masks and PRIMED Procedure Masks
    K Number
    K240286
    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
    Primed Medical Products Inc.
    Date Received
    February 1, 2024
    Decision Date
    August 26, 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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