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510(k) Data Aggregation

    K Number
    K990729
    Device Name
    FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
    Manufacturer
    ACC INTL.
    Date Cleared
    1999-05-13

    (69 days)

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

    FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES

    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 State.

    Device Description

    Famous Physicians Brand™ Disposable Acupuncture Needles

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for acupuncture needles, which confirms substantial equivalence to a predicate device. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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