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510(k) Data Aggregation

    K Number
    K220238
    Device Name
    Cohitech Cottonlock Tampons with Reusable Applicator
    Date Cleared
    2022-02-25

    (28 days)

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

    Cotton High Tech, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    The subject device is an unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on three absorbencies: regular (6-9g), super (9-12g) and super plus (12-15g). Each COHITECH Cottonlock tampon is individual wrapped in a cellulose paper along with the reusable applicator in its carrying case and packaqed in a sealed multi-unit cardboard containers for retail sale. The subject device deals with inclusion of a reusable tampon applicator, cleared under K212479, to the packaging of tampons cleared under K211775.
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