BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

    K Number: K881478 · Decision Sep 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    161

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    Basic Information

    Device Name
    MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
    K Number
    K881478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Keymed (Medical & Industrial Equipment), Ltd.
    Date Received
    April 6, 1988
    Decision Date
    September 14, 1988
    Product Code
    KNQ
    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
    KNQ Dilator, Esophageal

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