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510(k) Data Aggregation

    K Number
    K971062
    Device Name
    OPPORTUNITY INC. GENERAL PURPOSE TRAY
    Manufacturer
    OPPORTUNITY, INC.
    Date Cleared
    1997-06-09

    (77 days)

    Product Code
    LRO
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPPORTUNITY INC. GENERAL PURPOSE TRAY

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

    Opportunity Inc.'s General Purpose Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing general surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a "General Purpose Tray" and does not contain information about the acceptance criteria, device performance, or study details as outlined in the request. The letter only states that the device is substantially equivalent to legally marketed predicate devices and addresses regulatory aspects such as labeling, drug components, and general controls.

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

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