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

    Closed System Transfer Device

    K Number: K201460 · Decision Nov 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    904

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    Basic Information

    Device Name
    Closed System Transfer Device
    K Number
    K201460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shinva Ande Healthcare Apparatus Co., Ltd.
    Date Received
    June 2, 2020
    Decision Date
    November 23, 2022
    Product Code
    ONB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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