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510(k) Data Aggregation

    K Number
    K230419
    Device Name
    Sequel Tampon with Plastic Applicator
    Manufacturer
    Tampro Inc
    Date Cleared
    2023-08-03

    (168 days)

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

    Tampro Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    The Sequel Tampon with Plastic applicator are menstrual tampons used to absorb menstrual fluid. These Tampons are available in Regular absorbency (6-9 grams). These Tampons are made from rayon fibers and a polyethylene/polyester overwrap in which a cotton/polyester withdrawal cord is inserted. The applicator is a compact style polyethylene applicator with cylindrical barrel with a plunger. The assembled tampon with applicator is wrapped in a printed polypropylene wrapper. The tampon and applicator are single-use and non-sterile.
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