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510(k) Data Aggregation

    K Number
    K980899
    Device Name
    JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID
    Date Cleared
    1998-06-11

    (93 days)

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

    KENSHIN TRADING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States. The device is intended for single use only.
    Device Description
    JIN acupuncture needles are EtO sterilized, surgical grade stainless steel with pyrogen free for single-use only. JIN needles comply with the GMP quality and safety requirements. JIN needles use tightly secured metal handle for safe, excellent handling and are easy to use.
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