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

    ESKA MULTISTAGE ESOPHAGEAL BOUGIE

    K Number: K843186 · Decision Jan 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    20
    Review Days
    158

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    Basic Information

    Device Name
    ESKA MULTISTAGE ESOPHAGEAL BOUGIE
    K Number
    K843186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dacomed Corp.
    Date Received
    August 13, 1984
    Decision Date
    January 18, 1985
    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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