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510(k) Data Aggregation

    K Number
    K024160
    Device Name
    NEOSPORIN SCAR SOLUTION
    Manufacturer
    WARNER-LAMBERT CO.
    Date Cleared
    2003-03-17

    (90 days)

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

    WARNER-LAMBERT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    [Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
    Device Description
    [Trade Name] is a self-adhesive, fabric-backed, semi-disposable silicone sheet. The main component of the product is a proprietary material called Silon®. The basic Silon material is made from a blend of medical grade silicone and polytetrafluoroethylene ("PTFE") in the form of an interpenetrating polymer network. [Trade Name] is not sterile and does not contain antibiotics. [Trade Name] is not intended for use on open wounds. Each package of [Trade Name] contains 30 individual sheets (1.5" x 3"). Each sheet can be cut to fit the size of the scar or applied side-by-side, depending on the size of the scar.
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