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510(k) Data Aggregation

    K Number
    K141473
    Device Name
    SMC ACUPUNCTURE NEEDLE
    Manufacturer
    SMC INTL., INC.
    Date Cleared
    2014-08-01

    (59 days)

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

    SMC INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SMC ACUPUNCTURE NEEDLE is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The Acupuncture Needles are sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points". The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation and/or ethylene oxide. The Acupuncture Needles are available in nine needle diameters (0.16 to 0.70 mm), ten needle lengths (15-135 mm), and ten tube lengths (30-160 mm).
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