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510(k) Data Aggregation

    K Number
    K152350
    Device Name
    Regular and Special Umbilical Cord Clamp and Cutter
    Date Cleared
    2016-06-28

    (313 days)

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

    NINGBO FEITE MEDICAL DEVICE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery
    Device Description
    "Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery. "Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.
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