BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SILVERLON DIRECT PRESSURE WOUND DRESSING

    K Number: K984207 · Decision Mar 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    8
    Review Days
    3037

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    Basic Information

    Device Name
    SILVERLON DIRECT PRESSURE WOUND DRESSING
    K Number
    K984207
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Argentum International, LLC
    Date Received
    November 24, 1998
    Decision Date
    March 19, 2007
    Product Code
    KMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KMF Bandage, Liquid

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    Other Clearances by Argentum International, LLC

    K Number Device Name
    K984205 SILVERLON ADHESIVE STRIP
    K984204 SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
    K023612 SILVERLON CONTACT WOUND DRESSING
    K023609 SILVERLON ADHESIVE STRIP
    K984210 SILVERLON WOUND PACKING STRIPS
    K984208 SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD
    K981299 SILVERLON CONTACT WOUND DRESSING