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510(k) Data Aggregation

    K Number
    K203565
    Device Name
    Surgical 3D Mask
    Manufacturer
    Inno Lifecare
    Date Cleared
    2021-10-19

    (316 days)

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

    Inno Lifecare

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical 3D Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, provided nonsterile.
    Device Description
    Not Found
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