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510(k) Data Aggregation
K Number
K212764Device Name
Medwell Technology Ltd Syringes, various sizes
Manufacturer
Date Cleared
2022-11-04
(430 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Medwell Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medwell Technology Polycarbonate Syringes are intended to inject fluids into or withdraw fluids from the body.
Device Description
The Medwell Technology PC Syringes are provided sterile or in bulk non-sterile for further processing (e.g. sterilization). They are single use devices consisting of rigid polycarbonate barrels with luer slip or luer lock tips and various colored plungers with a synthetic rubber tip (stopper). The syringe barrels are printed with graduated markings in cc (1- 30 milliliters) indicating the volume of liquid inside the various size syringe barrels.
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