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510(k) Data Aggregation

    K Number
    K130609
    Device Name
    VEEDA 100% COTTON MENSTRUAL TAMPON
    Manufacturer
    NATURALENA BRANDS, INC.
    Date Cleared
    2013-03-21

    (14 days)

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

    NATURALENA BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Naturalena 100% Cotton Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
    Device Description
    The device will be offered as a traditional unscented menstrual 100% 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 three absorbencies: Regular, Super, and Super Plus.
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