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

    STERILE FLUID PRODUCING UNIT #EP550

    K Number: K832040 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    9
    Review Days
    97

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    Basic Information

    Device Name
    STERILE FLUID PRODUCING UNIT #EP550
    K Number
    K832040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    June 24, 1983
    Decision Date
    September 29, 1983
    Product Code
    LJH
    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
    LJH System, Irrigation, Urological

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