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510(k) Data Aggregation

    K Number
    K091084
    Device Name
    MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
    Manufacturer
    COTTON HIGH TECH SL
    Date Cleared
    2009-04-29

    (14 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    COTTON HIGH TECH SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be inserted into the vagina to absorb menstrual fluid. Cotton menstrual tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. These tampons will be provided as three absorbencies: regular, super and super plus. Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
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