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510(k) Data Aggregation

    K Number
    K102007
    Device Name
    PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2010-12-22

    (159 days)

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

    PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,

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

    The interestly and analogs'is vila lions For Ose. The 1977 her in and analgesia vila blockade of peripheral nerves.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Prolong Continuous Nerve Block Set." It indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any other details related to a scientific study proving the device meets acceptance criteria.

    The letter is a regulatory document confirming clearance, not a scientific publication detailing a study. Therefore, I cannot extract the requested information from the provided text.

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