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

    SIGMOIDOSCOPE, FLEXIBLE

    K Number: K822765 · Decision Nov 17, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    SIGMOIDOSCOPE, FLEXIBLE
    K Number
    K822765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Harvard Laboratories
    Date Received
    September 14, 1982
    Decision Date
    November 17, 1982
    Product Code
    FAM
    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
    FAM Sigmoidoscope And Accessories, Flexible/Rigid

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