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510(k) Data Aggregation

    K Number
    K991617
    Device Name
    FACE-2-FACE CPR PROTECTION SHIELD
    Date Cleared
    1999-11-03

    (177 days)

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

    WHITELINE PLASTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The above named device is designed to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins.
    Device Description
    FACE - 2 - FACE CPR PROTECTION SHIELD
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