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

    PILLING ESOPHAGEAL BOUGIES

    K Number: K133439 · Decision Jun 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    64
    Review Days
    216

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    Basic Information

    Device Name
    PILLING ESOPHAGEAL BOUGIES
    K Number
    K133439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflexmedical, Inc.
    Date Received
    November 12, 2013
    Decision Date
    June 16, 2014
    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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