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

    LAZARUS-NELSON PERITONEAL LAVAGE TRAY

    K Number: K813336 · Decision Dec 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    15
    Applicant Total
    64
    Review Days
    24

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    Basic Information

    Device Name
    LAZARUS-NELSON PERITONEAL LAVAGE TRAY
    K Number
    K813336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    November 24, 1981
    Decision Date
    December 18, 1981
    Product Code
    FKO
    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
    FKO Catheter, Peritoneal Dialysis, Single Use

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