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

    TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE

    K Number: K052846 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    90
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
    K Number
    K052846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maanshan Medical Instruments Co., Ltd.
    Date Received
    October 7, 2005
    Decision Date
    December 22, 2005
    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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