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

    ESOPHAGEAL DILATOR SET

    K Number: K842679 · Decision Oct 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    46
    Review Days
    84

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    Basic Information

    Device Name
    ESOPHAGEAL DILATOR SET
    K Number
    K842679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mill-Rose Laboratory
    Date Received
    July 10, 1984
    Decision Date
    October 2, 1984
    Product Code
    FAT
    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
    FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

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