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510(k) Data Aggregation

    K Number
    K971916
    Device Name
    MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
    Manufacturer
    Date Cleared
    1997-07-29

    (67 days)

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

    MEDICAL Z, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and keloids resulting from wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.
    Device Description
    The Medigel Z is a combination of a tri-block polymer and mineral oil. Medigel Z sheets are available in two thicknesses, 3 mm and 5 mm. The 3 mm sheets are 4 inches by 4 inches. The 5 mm sheets are available in three sizes: 8 by 8 inches, 12 by 16 inches, and 16 by 20 inches. The 5 mm sheets are lined with a fabric backing. The Medigel Z is also available in four different sized elastic sleeves. The sleeves are 9.5 inches long and range from 12 to 55 inches in circumference. The Medigel Z is also available as an unlined finger-tube, a fabric lined sternal strap, and an elastic lined glove (open finger tips) and chin strap. The Medigel Z also is available with an adhesive which eliminates the need for a compression bandage in most cases. The adhesive Medigel Z is available with or without a fabric backing and comes in sheets or circular pads. The "Mammopatch Gel Z" and "Abdopatch Gel Z" are fabric backed versions of the adhesive Medigel Z that are shaped specifically for use on the breast and abdomen.
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