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510(k) Data Aggregation

    K Number
    K073053
    Device Name
    COLPO-MASTER
    Date Cleared
    2007-11-15

    (16 days)

    Product Code
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    **UNITED PRODUCTS **& INSTRUMENTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNICO Colpo-Master Colposcope is indicated for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy
    Device Description
    The Colposcope consists of three main assemblies: Microscope head and lens; Stand; and Illuminator. . The microssope 200m head magnifies the arca of the human body to be observed by a physician. It works like a "tclcscope" and the closest point is more than 300mm away from the body part. The microscope head and lens are made of optical glass, brass, stecl, and aluminum.
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