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510(k) Data Aggregation

    K Number
    K972737
    Device Name
    CAUSSE PISTON
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-09-05

    (45 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MedNet Locator, INC., Piston Prosthesis is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.

    Device Description

    Piston Prosthesis

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The documents are an FDA 510(k) clearance letter and an Indications For Use statement for a "Piston Prosthesis" by MedNet Locator, Inc. They confirm the device's substantial equivalence to a predicate device and its intended use, but they do not contain details on performance studies, acceptance criteria, or the methodology of such studies.

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