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510(k) Data Aggregation

    K Number
    K132490
    Device Name
    SKORE AND MULTIPLE BRANDS
    Manufacturer
    TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L
    Date Cleared
    2014-10-20

    (438 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKORE Natural, SKORE Dots Natural, SKORE Bulbous Natural and SKORE Bulbous Dots & Ribs Natural - Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    SKORE Natural, SKORE Dots Natural and SKORE Bulbous Dots & Ribs Natural - Male Natural Rubber Latex Condoms.
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