LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K090819
    Device Name
    ONTEX TAMPON (UNSCENTED)
    Manufacturer
    ONTEX INTERNATIONAL NV
    Date Cleared
    2009-12-23

    (273 days)

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

    ONTEX INTERNATIONAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ontex 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
    The tampons to be marketed are conventional unscented menstrual tampons consisting of an absorbent pledget, with and without applicator.
    Ask a Question

    Page 1 of 1