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    K Number
    K963287
    Device Name
    VACUUM CUP (004SD)
    Manufacturer
    SWIFT DELIVERY PRODUCTS
    Date Cleared
    1996-10-28

    (68 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K890307
    Why did this record match?
    Reference Devices :

    K890307

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

    Vacuum Extractor Cup used in child birth

    Device Description

    The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called "The Tulip Cup" and its comparison to an existing device, Mityvac. It mentions a survey of physicians indicating an improvement was needed in vacuum products, but it does not provide details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, or any studies demonstrating the device meets specific acceptance criteria in a structured scientific manner.

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