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510(k) Data Aggregation

    K Number
    K083718
    Device Name
    BEAU RX SCAR CARE GEL
    Manufacturer
    BEAU RX SOLUTIONS, LLC.
    Date Cleared
    2009-01-26

    (42 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEAU RX SOLUTIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Beau RX™ Scar Care Gel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting for burns, general surgical procedures and trauma wounds
    Device Description
    Beau RxTM Scar Care Gel is a non sterile viscous emulsion/gel formulation, which is presented for over-the-counter use It is applied topically to aid in the management of both old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds
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