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

    TK Insulin Syringe with/without Saftey Retractable Device

    K Number: K191639 · Decision Sep 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    12
    Review Days
    450

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    Basic Information

    Device Name
    TK Insulin Syringe with/without Saftey Retractable Device
    K Number
    K191639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Received
    June 19, 2019
    Decision Date
    September 11, 2020
    Product Code
    MEG
    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
    MEG Syringe, Antistick

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    Other Clearances by Anhui Tiankang Medical Technology Co., Ltd.

    K Number Device Name
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    K212368 Surgical Face Mask
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