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510(k) Data Aggregation

    K Number
    K073187
    Device Name
    PERIPHERAL NERVE BLOCK SUPPORT TRAY
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2008-04-22

    (161 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERIPHERAL NERVE BLOCK SUPPORT TRAY

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

    Peripheral Nerve Block Support Tray is used for administration The egional or local anestheria to a patient

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Peripheral Nerve Block Support Tray." This letter is an approval for marketing the device and primarily focuses on its substantial equivalence to predicate devices, regulatory classifications, and general controls.

    Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or any details typically found in a clinical study report or technical specification document.

    Therefore, I cannot answer your request based on the provided input. The information you are asking for is simply not present in this regulatory clearance letter.

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