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510(k) Data Aggregation

    K Number
    K014268
    Device Name
    NORAPAD PLAIN; NORAPAD TA
    Manufacturer
    PERLEI MEDICAL, INC.
    Date Cleared
    2002-03-27

    (90 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K993019
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERLEI MEDICAL, INC.

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

    Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Norapad Cottonoid) and does not contain information regarding an AI/ML study. It is a premarket notification for a traditional medical device, comparing it to a predicate device for substantial equivalence, focusing on its intended use, materials, and manufacturing.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), or ground truth, as these concepts are not applicable to the content of this 510(k) submission.

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