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510(k) Data Aggregation

    K Number
    K131338
    Device Name
    DERMA HOOD
    Manufacturer
    GLOBALMEDIA GROUP, LLC
    Date Cleared
    2013-07-10

    (62 days)

    Product Code
    PEQ
    Regulation Number
    880.6320
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBALMEDIA GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.).
    Device Description
    The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses.
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