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510(k) Data Aggregation

    K Number
    K023966
    Device Name
    DISPOSABLE BI-POLAR CABLE
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2003-02-27

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable Bi-polar cables are used in conjunction with electrosurgery Disposable Di polar cables are accase ectrosurgical power for cauterizing during surgery.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria for a study, device performance data, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or ground truth establishment.

    Therefore, I cannot fulfill your request using the provided text. This document is a regulatory approval notice, not a study report.

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