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510(k) Data Aggregation

    K Number
    K092870
    Device Name
    NON-STERILE DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    KUNSHAN DEYI PLASTIC CO., LTD.
    Date Cleared
    2010-02-16

    (151 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    KUNSHAN DEYI PLASTIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.
    Device Description
    The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.
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