BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001

    K Number: K010607 · Decision Nov 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    7
    Review Days
    272

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    Basic Information

    Device Name
    MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
    K Number
    K010607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benlan, Inc.
    Date Received
    March 1, 2001
    Decision Date
    November 28, 2001
    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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