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

    Mic-Key* SF Over-the-Wire Stoma Measuring Device

    K Number: K173955 · Decision Jan 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    Mic-Key* SF Over-the-Wire Stoma Measuring Device
    K Number
    K173955
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Halyard Health, Inc.
    Date Received
    December 28, 2017
    Decision Date
    January 26, 2018
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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