BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    ESTEEM INCONTINENT SYSTEM

    K Number: K852276 · Decision Aug 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    417
    Registration Numbers
    418
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    ESTEEM INCONTINENT SYSTEM
    K Number
    K852276
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5920
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Bevan Medical, Inc.
    Date Received
    May 29, 1985
    Decision Date
    August 7, 1985
    Product Code
    EYQ
    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
    EYQ Garment, Protective, For Incontinence

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    Other Clearances by Bevan Medical, Inc.

    K Number Device Name
    K860459 UNITY DISPOSABLE INCONTINENT BRIEF