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510(k) Data Aggregation

    K Number
    K103061
    Device Name
    BIOMATE STERILE ACUPUNCTURE NEEDLE
    Manufacturer
    BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
    Date Cleared
    2011-06-20

    (245 days)

    Product Code
    MQX,MOX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOMATE STERILE ACUPUNCTURE NEEDLE

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

    Biomate Sterile Acupuncture Needle, Model: Nano, Nano-PI, Nano-EI is intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter for a medical device (acupuncture needles) and does not contain the information requested regarding acceptance criteria and a study proving device performance. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

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

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