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510(k) Data Aggregation

    K Number
    K182817
    Device Name
    CottonDay Tampon
    Manufacturer
    Taebong Co., Ltd
    Date Cleared
    2019-07-22

    (292 days)

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

    Taebong Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.
    Device Description
    CottonDay Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
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