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

    VITALA CONTINENCE CONTROL DEVICE

    K Number: K111365 · Decision Aug 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    95

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    Basic Information

    Device Name
    VITALA CONTINENCE CONTROL DEVICE
    K Number
    K111365
    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, Inc.
    Date Received
    May 16, 2011
    Decision Date
    August 19, 2011
    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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