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510(k) Data Aggregation

    K Number
    K070534
    Device Name
    MODIFICATION TO: OCU-FILM TIP COVER
    Manufacturer
    REICHERT, INC.
    Date Cleared
    2007-03-27

    (29 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Special
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO: OCU-FILM TIP COVER

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

    The Ocu-Film Tip Cover is intended to be used to protect the Tono-Pen transducer from dust and fluids, and helps protect patients from risk of cross-contamination.

    Device Description

    Ocu-Film Tip Cover

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Ocu-Film Tip Cover." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter states that the Ocu-Film Tip Cover is substantially equivalent to legally marketed predicate devices and is intended to protect Tono-Pen transducers from dust and fluids, and to help protect patients from the risk of cross-contamination.

    Therefore, I cannot provide the requested information because it is not present in the provided text.

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