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510(k) Data Aggregation

    K Number
    K082042
    Device Name
    GONGDONG DISPOSABLE SHARP CONTAINER
    Manufacturer
    ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
    Date Cleared
    2008-09-03

    (47 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gongdong Disposable Sharps Container is intended to be used in the healthcare facilities for the safe disposal of hazardous sharps.
    Device Description
    Not Found
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    K Number
    K050887
    Device Name
    GONGDONG DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
    Date Cleared
    2005-07-11

    (95 days)

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

    ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gongdong 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
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