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510(k) Data Aggregation

    K Number
    K100665
    Device Name
    MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
    Manufacturer
    NEEDLETECH PRODUCTS, INC.
    Date Cleared
    2010-06-24

    (108 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K131157
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MARROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

    Device Description

    MARROWMAX Bone Marrow Aspiration Needle Kit

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a bone marrow aspiration needle kit. It confirms substantial equivalence to a predicate device but does not contain any information about acceptance criteria, performance data, or studies that prove the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval for marketing the device.

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