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510(k) Data Aggregation

    K Number
    K020959
    Device Name
    GLO-SPEC I, II AND III
    Manufacturer
    Date Cleared
    2002-06-19

    (86 days)

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

    SOL WEISS MD INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.
    Device Description
    The devices are made of injected molded parts. Does not require assembly (simple product). Has vents to allow heat to escape. No contact with body surfaces. Has interlocking cone for device attachment. The device is for single use only.
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    K Number
    K013817
    Device Name
    GLO-SPEC
    Manufacturer
    Date Cleared
    2001-12-21

    (35 days)

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

    SOL WEISS MD INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use is interconnection of devices for transmission of light. The intended use is to illuminate area of view. The intended use is the interconnection of devices for transmission of light.
    Device Description
    Not Found
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    K Number
    K012859
    Device Name
    NU-SPEC D
    Manufacturer
    Date Cleared
    2001-10-26

    (63 days)

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

    SOL WEISS MD INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is to be used for exposing the interior of the vagina.
    Device Description
    - The device is made of injected molded parts . - The device assembly includes a window trap for pins to snap together ● - The instrument has levels in the windows to lock positions as desired . by the expanding vertical blades - The lateral blade protectors act to prevent lateral walls from cascading ● into view area. - Lateral protector blades are same thickness of vertical blades thus act as rigid barriers - Lateral protector blades conform with the design of vertical blade that . provide rigid conforming structures that allows smooth unchanged entrance The device once snapped together do not require any further assembly - The device is for single use only
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