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510(k) Data Aggregation

    K Number
    K100234
    Device Name
    HM-LAMP II
    Manufacturer
    HILLUSA, INC.
    Date Cleared
    2010-07-08

    (163 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    HILLUSA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HM-LAMP II is a device intended to be used to provide visible illumination of the surgical/field or the patient. They are designed for minor surgical procedures.
    Device Description
    The HM-LAMP II Series are operating lamps with high performance. Flexible movement arm and mobile stand. Designed for minor surgical procedures as well as additional operating room needs.
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