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510(k) Data Aggregation

    K Number
    K974143
    Device Name
    KMC NEWSKIN
    Manufacturer
    KMC INTL. CO.
    Date Cleared
    1998-03-27

    (144 days)

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

    KMC INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KMC Ultra-Sil Scar Management System is a thin, soft silicone KMC ofera-SIF Scar handyement application for keloid and hypertrophic scar management. KMC Ultra-Sil Scar Management System is intended to be used only on healed scars.
    Device Description
    KMC Ultra-Sil Scar Management System is a thin, soft silicone sheet designed to be applied externally, in a non-invasive manner to healed keloid and hypertrophic scars. Scar area is to be washed and towel dried before application. KMC Ultra-Sil Scar Management System is applied to scar area with 1/2 inch overlap. Initial application to last 2-3 hours. Successive applications will increase contact by 1 hour each until 8 hour contact is reached. Application time of 20 hours is recommended.
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