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510(k) Data Aggregation

    K Number
    K052912
    Device Name
    YUSHENG DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD.
    Date Cleared
    2005-12-15

    (59 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The YuSheng Disposable Vaginal Speculum is non sterile products and is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies. The document is an FDA 510(k) clearance letter for the YuSheng Disposable Vaginal Speculum, primarily focused on regulatory approval and indications for use. It doesn't include the technical performance data that would typically be found in a study report.

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