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510(k) Data Aggregation

    K Number
    K191431
    Device Name
    Interlude Rolled Tampons in Plastic Applicator
    Manufacturer
    ALBAAD fem
    Date Cleared
    2019-10-07

    (131 days)

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

    ALBAAD fem

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
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    K Number
    K181911
    Device Name
    Interlude 100% Cotton Tampon
    Manufacturer
    ALBAAD fem
    Date Cleared
    2018-11-02

    (108 days)

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

    ALBAAD fem

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.
    Device Description
    Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies: Light: <6 grams Regular: 6-9 grams Super: 9-12 grams
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    K Number
    K173225
    Device Name
    Interlude and private label Unscented 3-piece compact applicator tampon
    Manufacturer
    ALBAAD fem
    Date Cleared
    2018-06-15

    (255 days)

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

    ALBAAD fem

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interlude and private label Unscented 3-piece applicator tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Interlude and private label Unscented 3-piece compact applicator tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 2 absorbencies, regular and super. These tampons are made from rayon fibers and polymeric overwrap. The withdrawal cord is made of cotton and polyester. The applicator tubes are made of polyethylene (PE) and include a cylindrical barrel with a finger grip and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
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