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    K Number
    K964956
    Device Name
    E-Z SPACER MASK (SMALL)
    Manufacturer
    AIRPHARMA, LLC
    Date Cleared
    1997-04-23

    (133 days)

    Product Code
    CCQ
    Regulation Number
    868.5640
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRPHARMA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The E-Z SPACER® Mask (Small) uses FDA approved materials: Dynaflex G2706 Kraton thermoplasiic rubber designed for medical applications, and 21 CFR 178.3297 colorant pigments as specified by the Food and Drug Administration (Colorants for polymers). The E-Z SPACER Mask is injected molded with cavity I.D. mask (E-Z SPACER®MASK (Small) for identification.
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