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510(k) Data Aggregation

    K Number
    K021095
    Device Name
    HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
    Date Cleared
    2002-05-17

    (43 days)

    Product Code
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
    Device Description
    The Holy Dragon Brand Acupuncture Needles are sterile disposable, surgical stainless steel with a spiral wound silver or copper handle that is mechanically attached. The needles are supplied individually blister sealed packaged with polypropylene insertion tubes and medical grade paper. They are sold in paper carton boxes in quantities of either 100 or 500 needles per box. Statements "For single use only," "Federal law restricts this device to sale by or on the order of qualified practitioners of acupuncture as determined by the States," "Pyrogen Free," and "made in China" are shown in box labeling.
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