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510(k) Data Aggregation

    K Number
    K983478
    Device Name
    ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
    Manufacturer
    ORGANIC ESSENTIALS
    Date Cleared
    1998-11-09

    (38 days)

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

    ORGANIC ESSENTIALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Organic Essentials Organically Grown Cotton Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
    Device Description
    Organic Cotton Tampon
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