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510(k) Data Aggregation

    K Number
    K013835
    Device Name
    GLOBAL HEALTHCARE VAGINAL SPECULUM
    Date Cleared
    2002-01-17

    (59 days)

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

    DYNASCEND CONSULTING INT'L LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Global Healthcare's Vaginal Speculum is intended to be used for general vaginal operation in which it is inserted into the vagina to expose the cervix.
    Device Description
    Not Found
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