BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Regular and Special Umbilical Cord Clamp and Cutter

    K Number: K152350 · Decision Jun 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    313

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    Basic Information

    Device Name
    Regular and Special Umbilical Cord Clamp and Cutter
    K Number
    K152350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Feite Medical Device Co., Ltd.
    Date Received
    August 20, 2015
    Decision Date
    June 28, 2016
    Product Code
    NBZ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBZ Clamp And Cutter, Umbilical