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510(k) Data Aggregation

    K Number
    K973853
    Device Name
    KOLPLAST VAGINAL SPECULUM
    Date Cleared
    1997-12-19

    (72 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOLPLAST COMERCIAL E INDUSTRIAL LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kolplast Vaginal Speculum is a disposable plastic speculum used to expose the interior of the vagina.
    Device Description
    Kolplast Vaginal Speculum
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