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

    HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.

    K Number: K895524 · Decision Apr 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
    K Number
    K895524
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Theramed, Inc.
    Date Received
    September 12, 1989
    Decision Date
    April 10, 1990
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Theramed, Inc.

    K Number Device Name
    K910004 FURUI SHUNT, 2-WAY AND 3-WAY