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

    Enteral Feeding Sets

    K Number: K240039 · Decision Apr 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    2
    Review Days
    103

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    Basic Information

    Device Name
    Enteral Feeding Sets
    K Number
    K240039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Primecare Medical Co., Ltd.
    Date Received
    January 5, 2024
    Decision Date
    April 17, 2024
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Hangzhou Primecare Medical Co., Ltd.

    K Number Device Name
    K202698 Prefilled Syringe