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510(k) Data Aggregation

    K Number
    K083840
    Date Cleared
    2009-09-28

    (278 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
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    Device Name :

    MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE

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

    Rigid Endoscopes

    MSI MedServ International Deutschland GmbH rigid endoscopes and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals.

    Device Description

    A rigid endoscope is a tubular endoscopic device with any of a group of accessory devices which attach to the endoscope and is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals. It is typically used with a Fiberoptic light source and carrier to provide illumination.

    AI/ML Overview

    This is not an AI/ML device and therefore the requested information is not applicable.

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