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510(k) Data Aggregation
K Number
K161812Device Name
Freedom Syringe
Manufacturer
Date Cleared
2017-03-27
(269 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Procedure Products, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Freedom™ Syringe is intended to inject fluids into, or withdraw fluids from, the body.
Device Description
The Freedom™ Syringe is a single-use medical device consisting of a calibrated hollow barrel and movable plunger (piston). The plunger contains a rubber stopper on the end that is positioned within the syringe barrel. A small amount of medical-grade silicone is used as a lubricant. The lubricant, stopper on the end of the plunger, and the syringe barrel are the components which make contact with the fluid path of the device. The syringe barrel contains a standard male luer lock connector that is compatible with standard female luer hubs. Freedom™ Syringes have a nominal capacity of 10ml, and are available sterile or non-sterile for further processing. The syringe is available in 5 different plunger colors: white, blue, red, yellow, or green.
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