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510(k) Data Aggregation

    K Number
    K030315
    Device Name
    MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
    Manufacturer
    Date Cleared
    2003-02-27

    (28 days)

    Product Code
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTROID, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III , IV.
    Device Description
    Not Found
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    K Number
    K023706
    Device Name
    ULTROID HEMORRHOID MANAGEMENT SYSTEM
    Manufacturer
    Date Cleared
    2003-01-14

    (71 days)

    Product Code
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTROID, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III, IV.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

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