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510(k) Data Aggregation

    K Number
    K112131
    Device Name
    NEODYNE DRESSING
    Manufacturer
    NEODYNE BIOSCIENCES, INC.
    Date Cleared
    2011-09-29

    (65 days)

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

    NEODYNE BIOSCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
    Device Description
    The Neodyne Dressing is a non-sterile, single use adhesive silicone sheet to be used to protect and manage a newly formed, closed scar. The Dressing is pre-strained prior to application and applied over the new scar. The silicone sheeting protects and stress shields the scar.
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