Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133493
    Device Name
    SINGLE USE STERILE SYRINGE WITH NEEDLE
    Date Cleared
    2014-03-27

    (133 days)

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

    JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Single Use Sterile Syringe with Needle inject fluids into or withdraw fluid from, parts of the bady below the surface of the skin.
    Device Description
    The Single Use Sterile Syringe with Needle belongs to standard piston. And there are eight models - 1ml,2ml,2.5ml,5ml,10ml,20ml,30ml and 50ml within the device, which enjoy the same stucture, that is, all of the eight models consists of a piston syringe comprised of a movable plunger, piston and a calibrated hollow barrel, at one end of which there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle, and a matching hypodermic single lumen needle which consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designated to mate with a male connector (nozzle) of a piston syringe.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1