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510(k) Data Aggregation
K Number
K124037Device Name
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
Manufacturer
Date Cleared
2013-09-12
(258 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
JUNG RIM MEDICAL INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Jung Rim single use hypodermic syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Device Description
The Single use hypodermic Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The product consists of a Barrel, Piston, Gasket, Needle Needle cap. The Single use hypodermic Syringe with Needle are offered various sizes (Luer slip (1.3.5,10,20,30,50 (ml)), and Needle size (16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G) Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users. These are sterile (Eo gas sterilization). The devices are disposable, single use devices.
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