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510(k) Data Aggregation

    K Number
    K983092
    Device Name
    TRITON HUDSON CHUCK ATTACHMENT
    Manufacturer
    MEDNEXT, INC.
    Date Cleared
    1998-11-06

    (64 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.

    Device Description

    Hudson Chuck for Mednext TRITON Handpiece

    AI/ML Overview

    This request cannot be fulfilled. The document provided is a 510(k) clearance letter from the FDA, a statement of intended use, and the device name. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself or in published studies related to the device, neither of which are part of the provided text.

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