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510(k) Data Aggregation

    K Number
    K031684
    Device Name
    TOPKIN WOUND DRESSING
    Manufacturer
    BIOMET MERCK GMBH
    Date Cleared
    2003-10-30

    (153 days)

    Product Code
    QSZ, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET MERCK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.
    Device Description
    Topkin® foil is a synthetic, polymeric, transparent foil for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions. Topkin® adhesive is made from the same ingredients like the Topkin® foil plus Titanium dioxide and is used for the fixation of Topkin® foil on healthy skin. The fixation is mediated by cohesive forces between the Topkin® foil, the Topkin® adhesive and the healthy skin. Material used: Topkin® foil: Lactide-caprolactone copolymers Topkin® Adhesive: 99 % Oligocaprolactone-co-lactide and 1 % Titanium dioxide
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