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510(k) Data Aggregation

    K Number
    K092240
    Device Name
    ACUPUNCTURE NEEDLES
    Manufacturer
    HAENGLIM SEOWON MEDICAL CO.
    Date Cleared
    2010-04-21

    (272 days)

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

    HAENGLIM SEOWON MEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device 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. The Acupuncture Needles are available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).
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