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U.S. Department of Health and Human Services

Product Classification

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Device syringe, piston, reprocessed
Regulation Description Piston syringe.
Definition A piston syringe is a device intended for medical purposes 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 device is used to inject fluids into, or withdraw fluids from, the body.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeNKN
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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