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

    KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE

    K Number: K980471 · Decision Apr 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    90
    Applicant Total
    5
    Review Days
    62

    Basic Information

    Device Name
    KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
    K Number
    K980471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMERICAN INSTITUTE OF KORYO HAND THERAPY
    Date Received
    February 6, 1998
    Decision Date
    April 9, 1998
    Product Code
    MQX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQX Needle, Acupuncture, Single Use

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