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510(k) Data Aggregation

    K Number
    K210772
    Device Name
    3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
    Manufacturer
    VR Vertical LLC dba XRGO
    Date Cleared
    2021-09-22

    (191 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    VR Vertical LLC dba XRGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This single-use face mask covers the wearer's nose and mouth, providing a general physical barrier to protect the wearer from the environment, and the environment from the wearer. This device is designed to spatter of blood and other infectious materials.
    Device Description
    Not Found
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