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510(k) Data Aggregation

    K Number
    K092054
    Device Name
    MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
    Manufacturer
    TOSAMA D.D.
    Date Cleared
    2009-07-29

    (22 days)

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

    TOSAMA D.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MOXIE tampons (both types) are unscented tampons for: • Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. • The plastic applicator is for easing the placement of the tam pon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).
    Device Description
    The MOXIE tampons are used to absorb menstrual fluid. The MOXIE series tampons come with a plastic applicator and without a plastic applicator in sizes: Regular, Super ,Super plus and Ultra. The MOXIE tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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    K Number
    K080775
    Device Name
    MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
    Manufacturer
    TOSAMA D.D.
    Date Cleared
    2008-09-10

    (175 days)

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

    TOSAMA D.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAXIM tampons (both types) are unscented tampons for: - Women's personal hygiene with respect to intra vaginal absorption of . menstrual or other vaginal discharge. . - The plastic applicator is for easing the placement of the tampon correctly into . the vagina (only the MAXIM Plastic Applicator Tampon).
    Device Description
    The Maxim tampons are used to absorb menstrual fluid. The Maxim series tampons comes with plastic applicator and without in sizes: Regular, Super, Super plus, Ultra. The Maxim tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
    Ask a Question

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