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510(k) Data Aggregation

    K Number
    K190002
    Device Name
    Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
    Manufacturer
    Shanghai Kohope Medical Devices Co., Ltd
    Date Cleared
    2019-09-12

    (253 days)

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

    Shanghai Kohope Medical Devices Co., Ltd

    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 callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin. The sterile Insulin Syringe for Single use with the callbration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts 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 plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Configuration: Piston, Plunger, Barrel, (Needle) for Hypodermic Syringe; Needle cover, Needle, Piston, Barrel, Plunger, End cap for Insulin Syringe; Protective cap, Needle tube, Adhesives, Needle hub for Hypodermic Needle. Operation Mode: For manual use only. Nozzle: Luer Slip, Luer Lock for Hypodermic Syringe and Hypodermic Needle; Fixed Needle for Insulin Syringe. Volume/Sizes: Luer slip: 1,2,3,5,10,20,30,35,50,60(ml), Luer Lock: 1,2,3,5,10,20,30,35,50,60(ml), 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Syringe; 0.3, 0.5, 1(ml), 29G, 30G, 31G for Insulin Syringe; 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Needle. Material: Plunger: polypropylene (PP); Barrel: polypropylene (PP); Piston: isoprene rubber; Hypodermic needle: polypropylene (PP), stainless steel; for Hypodermic Syringe; Needle cover: polypropylene (PP); Needle: stainless steel (SUS); Piston: isoprene rubber; Barrel: polypropylene (PP); Plunger: polypropylene (PP); End cap: polypropylene (PP); for Insulin Syringe; Protective cap: polypropylene (PP), Needle tube: stainless steel (SUS), Adhesives: epoxy resin, Needle hub: polypropylene (PP) for Hypodermic Needle.
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