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510(k) Data Aggregation

    K Number
    K090910
    Device Name
    HANSO ACUPUNCTURE NEEDLE
    Manufacturer
    HANSOL MEDICAL CO.
    Date Cleared
    2009-06-30

    (90 days)

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

    HANSOL MEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An 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 a handle attached to the needle to facilitate the delivery of acupuncture treatment.
    Device Description
    Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle. The Hansol acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Hansol acupuncture needle meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture.
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