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

    CSF-VENTRICULOSTOMY RESERVOIR

    K Number: K874498 · Decision Feb 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    40
    Review Days
    101

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    Basic Information

    Device Name
    CSF-VENTRICULOSTOMY RESERVOIR
    K Number
    K874498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Pudenz-Schulte Medical Research Corp.
    Date Received
    November 2, 1987
    Decision Date
    February 11, 1988
    Product Code
    LKG
    Advisory Committee
    Neurology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular

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