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

    SPIRIT ACUPUNCTURE NEEDLE

    K Number: K003010 · Decision Oct 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    90
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    SPIRIT ACUPUNCTURE NEEDLE
    K Number
    K003010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United Pacific Co., Ltd.
    Date Received
    September 26, 2000
    Decision Date
    October 19, 2000
    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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    Other Clearances by United Pacific Co., Ltd.

    K Number Device Name
    K001718 MILLENNIA ACUPUNCTURE NEEDLE
    K993123 QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B
    K991503 SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
    K990406 KINGLI ACUPUNCTURE NEEDLE