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

    VITALA CONTINENCE CONTROL DEVICE

    K Number: K083785 · Decision Apr 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    469

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    Basic Information

    Device Name
    VITALA CONTINENCE CONTROL DEVICE
    K Number
    K083785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec
    Date Received
    December 19, 2008
    Decision Date
    April 2, 2010
    Product Code
    EZQ
    Advisory Committee
    Gastroenterology, Urology
    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
    EZQ Pouch, Colostomy

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