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510(k) Data Aggregation
K Number
K111841Device Name
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
Date Cleared
2012-03-01
(246 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
CHENGDU XINJIN SHIFENG MED APPRATUS INST CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.
Device Description
The ShiFeng Disposable Syringe is a sterile, single use device consisting of a needle attached to a syringe. The ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to the IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969. The device consists of a metal tube that is sharpened at one end and the end joined to a female connector (hub) designated to mate with a male connector ( nozzle ) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.
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