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510(k) Data Aggregation
K Number
K133493Device Name
SINGLE USE STERILE SYRINGE WITH NEEDLE
Date Cleared
2014-03-27
(133 days)
Product Code
Regulation Number
880.5860Why 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.
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