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510(k) Data Aggregation

    K Number
    K072762
    Device Name
    DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
    Manufacturer
    DEPALT INC.
    Date Cleared
    2008-01-22

    (116 days)

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

    DEPALT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations. Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.
    Device Description
    Depalt Vaginal Speculum is a nonmetal, single use (disposable) medical device used to expose the interior of the vagina. The vaginal speculum may be used with or without the Depalt Lighting System. Depalt Lighting System provides the light necessary to illuminate during procedures and examinations.
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