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510(k) Data Aggregation

    K Number
    K992626
    Device Name
    SURE-WAY REUSABLE SHARPS CONTAINER
    Manufacturer
    SURE-WAY SYSTEMS, INC.
    Date Cleared
    1999-12-16

    (133 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURE-WAY REUSABLE SHARPS CONTAINER

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

    The Sure-Way Reusable Container is intended to be used for the disposal of contaminated medical sharps in health care facilities.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Sure-Way Reusable Sharps Container." It does not contain information on acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot answer your request based on the provided text. The document is primarily focused on the regulatory approval of the device and its intended use, not on performance studies or their results.

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