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

    Prefilled Syringe

    K Number: K202698 · Decision Dec 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    Prefilled Syringe
    K Number
    K202698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Primecare Medical Co., Ltd.
    Date Received
    September 16, 2020
    Decision Date
    December 15, 2020
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Hangzhou Primecare Medical Co., Ltd.

    K Number Device Name
    K240039 Enteral Feeding Sets