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510(k) Data Aggregation
K Number
K060211Device Name
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
Manufacturer
Date Cleared
2006-02-10
(14 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
WENZHOU WUZHOU GROUP CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Wuzhou Syringe, with/without needle for single use only, is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Device Description
The Wuzhou Syringe, with/without needle, is a standard piston syringe that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The syringe is designed for manual use. It is available in 1, 2, 3, 5, 10, 20, 30, 50, 60 and 100ml volumes, with luer slip, luer lock, centrally or eccentrically tip configurations. Syringe with 50 ml volume is irrigating syringe.
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