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510(k) Data Aggregation

    K Number
    K980091
    Device Name
    LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
    Manufacturer
    COSMACEUTICAL MARKETING, INC.
    Date Cleared
    1998-04-09

    (90 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMACEUTICAL MARKETING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.
    Device Description
    Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. The gel is not sterile. The raw materials comprising the gel have a long and established history as raw materials in cosmetics.
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