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

    P-S MED. LUMBO PERITONEAL & VENTRICULO-

    K Number: K823509 · Decision Dec 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    63
    Same Product Code
    252
    Applicant Total
    40
    Review Days
    20

    Basic Information

    Device Name
    P-S MED. LUMBO PERITONEAL & VENTRICULO-
    K Number
    K823509
    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 26, 1982
    Decision Date
    December 16, 1982
    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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