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    K Number
    K252939
    Device Name
    COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
    Manufacturer
    Cotton High Tech S.L.
    Date Cleared
    2025-10-09

    (24 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K211775
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (light, regular, super, and super plus) are inserted into the vagina and used to absorb menstrual fluids.

    Device Description

    The device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), surrounded by an organic cotton cover ("security veil"), and an organic cotton string ("withdrawal cord"). It features a compact, polyethylene applicator. The inner and outer tubes slide into each other telescopically, so the inner tube must be retracted before use.

    These tampons will be provided in four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton compact applicator tampon is either individually wrapped with cellulose paper or polypropylene and packaged in sealed multi-unit containers for retail sale. The wrapped device can also be sold in bulk.

    Device trade name COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS could be put into the market with various brands.

    AI/ML Overview

    N/A

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