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510(k) Data Aggregation

    K Number
    K984218
    Device Name
    OASIS
    Manufacturer
    GLIMEX CORP.
    Date Cleared
    1998-12-17

    (23 days)

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

    GLIMEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oasis™ brand condoms are used for contraccption and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted discascs).
    Device Description
    Oasis™ brand Male Natural Rubber Latex Condom, natural and color, silicone lubricated
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