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510(k) Data Aggregation

    K Number
    K974672
    Device Name
    MSI SURGICAL DRAPES
    Manufacturer
    MEDICAL SPECIALTY INNOVATIONS, INC. (MSI)
    Date Cleared
    1998-03-13

    (88 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MSI SURGICAL DRAPES

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

    The MSI Surgical Drapes are intended to be used as a protective patient drape during surgical procedures to isolate the site of the surgical incisions and assist in protecting the site from microbial and other contamination.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The text is a 510(k) clearance letter from the FDA for "MSI Surgical Drapes" and describes the regulatory approval process and indications for use. It does not include acceptance criteria, details of a study on device performance, sample sizes, information about experts or ground truth, or details about AI or MRMC studies.

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