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510(k) Data Aggregation

    K Number
    K052846
    Device Name
    TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
    Manufacturer
    MAANSHAN MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2005-12-22

    (76 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032640
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 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 for ease of acupuncture treatment.

    Device Description

    The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle for ease of acupuncture treatment.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an acupuncture needle. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

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