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510(k) Data Aggregation

    K Number
    K051446
    Device Name
    FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC INC.
    Date Cleared
    2005-07-14

    (42 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    First Quality Hygienic, Inc. Femtex and Private Label Scented plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance.
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