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510(k) Data Aggregation

    K Number
    K984115
    Device Name
    SCAREASE & SCAREASE ADHESIVE GEL
    Manufacturer
    SCAREASE, INC.
    Date Cleared
    1999-02-12

    (87 days)

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

    SCAREASE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - ScarEase is indicated for use in the management of hypertrophic and keloid scars. - ScarEase is effective in the management of hypertrophic and keloid scars. . - Consistent use of ScarEase can reduce hypertrophic and keloid scarring. . - lf used following surgical procedures, ScarEase may prevent hypertrophic . and keloid scarring.
    Device Description
    Not Found
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