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510(k) Data Aggregation

    K Number
    K112057
    Device Name
    KDL SYRINGES AND NEEDLE
    Manufacturer
    SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO.,
    Date Cleared
    2011-12-14

    (148 days)

    Product Code
    FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for single use with needle, with the calibration unit of U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    The proposed devices are Sterile Hypodermic Syringe for single use with/without Needle, Sterile Insulin Syringe for single use with Needle, and Sterile Hypodermic Needle for single use. The hypodermic syringes are available in Luer slip and Luer lock nozzles with volumes from 1ml to 50ml, made of PP, and can be with or without a needle. The insulin syringes have a fixed needle, are available in 0.3ml, 0.5ml, and 1ml volumes, made of PP, and come with a fixed needle. The hypodermic needles are available in Luer slip and Luer lock nozzles with gauges from 18G to 30G, made of Stainless Steel.
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