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510(k) Data Aggregation

    K Number
    K971090
    Device Name
    OPPORTUNITY DRESSING CHANGE TRAY
    Manufacturer
    OPPORTUNITY, INC.
    Date Cleared
    1997-09-16

    (176 days)

    Product Code
    KMF,K97
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPPORTUNITY DRESSING CHANGE TRAY

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

    Opportunity Inc.'s Dressing Change 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 in the change of dressings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Opportunity, Inc. regarding several medical device kits and trays. It primarily addresses the substantial equivalence determination for these devices, regulatory classifications, and general compliance requirements.

    Therefore, I cannot provide the requested information in the structured format.

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