BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LM Surgical Mask Level 3, LM Surgical Mask Level 2,

    K Number: K211378 · Decision Dec 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    1
    Review Days
    226

    Basic Information

    Device Name
    LM Surgical Mask Level 3, LM Surgical Mask Level 2,
    K Number
    K211378
    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
    Liberty Mask LLC
    Date Received
    May 4, 2021
    Decision Date
    December 16, 2021
    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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