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510(k) Data Aggregation

    K Number
    K192285
    Device Name
    CPR Face Shield
    Manufacturer
    Firstar Healthcare Company Limited (Guangzhou)
    Date Cleared
    2020-11-25

    (461 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Firstar Healthcare Company Limited (Guangzhou)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission.
    Device Description
    Not Found
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