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510(k) Data Aggregation

    K Number
    K062984
    Device Name
    MEDLINE HYPODERMIC NEEDLES
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2006-11-13

    (45 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medline Disposable Sterile Hypodermic Needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for Medline Hypodermic Needles. It does not contain any information about acceptance criteria, study details, or device performance data.

    The document discusses:

    • The FDA's determination of substantial equivalence to a legally marketed predicate device.
    • Regulatory classifications and requirements.
    • Indications for use of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text. The necessary information is not present in this document.

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