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510(k) Data Aggregation

    K Number
    K132390
    Device Name
    INSTINCT; PLAIN, DOTTED, ULTRA THIN
    Manufacturer
    PROFILATEX, S.A. DE C.V.
    Date Cleared
    2014-04-22

    (264 days)

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

    PROFILATEX, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Instinct brand condoms ( Instinct Plain, Instinct Dotted, Instinct Ultrathin) are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
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