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510(k) Data Aggregation

    K Number
    K974616
    Device Name
    SINGER ACUPUNCTURE NEEDLES
    Manufacturer
    LORAC, INC.
    Date Cleared
    1998-02-05

    (56 days)

    Product Code
    MQX,MOX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K962809,K962916
    Why did this record match?
    Applicant Name (Manufacturer) :

    LORAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

    Device Description

    The needles are sterile, for single use only. They have a stainless steel shaft and a polystyrol handles are color coded for size.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) summary and FDA clearance letter for "Singer Acupuncture Needles" which establishes substantial equivalence to predicate devices, but it does not include details on specific acceptance criteria or performance studies. It mentions "results of bench and user testing" but provides no specifics about these tests, the data, or the metrics.

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