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510(k) Data Aggregation

    K Number
    K150903
    Device Name
    EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
    Manufacturer
    MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2015-07-15

    (103 days)

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

    MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.
    Device Description
    The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.
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