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510(k) Data Aggregation
K Number
K080303Device Name
EZ REGULAR
Manufacturer
Date Cleared
2008-08-05
(182 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEINNTECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use X
Device Description
The EZ Regular consists of components commonly found on intravascular administration sets and extension sets. EZ Regular set consists of various components such as: air vented bag spike, drip chamber with filter or without filter, roller clamp, tubing, flow controller, Y-connector, needle-less Y-connector, luer lock end catheter, manifold filter.
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