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510(k) Data Aggregation

    K Number
    K030190
    Device Name
    CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
    Manufacturer
    SUZHOU SEN SEN MEDICAL SUPPLIES LTD.
    Date Cleared
    2003-02-21

    (31 days)

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

    SUZHOU SEN SEN MEDICAL SUPPLIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    Carbo/Optimed brand acupuncture needles are sterile disposable needle for one time use only. The needle shaft/body is made of surgical grade stainless steel (as per ASTM specifications) and is used for the practice of acupuncture as determined by state. The handle is made of aluminium alloy, which does not enter the human body, but is used to control the insertion of the needle.
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