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510(k) Data Aggregation

    K Number
    K963194
    Device Name
    ITO ACUPUNCTURE NEEDLES
    Manufacturer
    OMS MEDICAL SUPPLIES, INC.
    Date Cleared
    1996-08-23

    (8 days)

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

    OMS MEDICAL SUPPLIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
    Device Description
    The subject of this 510(k) application - the Ito acupuncture needle - is a sterile, single use only acupuncture needle. The Ito acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
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