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510(k) Data Aggregation

    K Number
    K991312
    Device Name
    SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
    Manufacturer
    LIBRARY MEDICAL, INC.
    Date Cleared
    1999-08-20

    (126 days)

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

    LIBRARY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used in the management of Hypertrophic and Keloid scars that are the result of surgery, trauma, and burns. Also, LMI Scar Management Silicone Sheeting may prevent Hypertrophic and Keloid scars from forming.
    Device Description
    Not Found
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