BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WILSON-COOK COLONIC Z-STENT

    K Number: K990034 · Decision Apr 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    26
    Review Days
    467

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    Basic Information

    Device Name
    WILSON-COOK COLONIC Z-STENT
    K Number
    K990034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Med Institute, Inc.
    Date Received
    January 6, 1999
    Decision Date
    April 17, 2000
    Product Code
    MQR
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQR Stent, Colonic, Metallic, Expandable

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