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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device low dead space piston syringe
Definition A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.
Product CodeQNQ
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FEELTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JEIL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDEXEL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH INC.
  SUBSTANTIALLY EQUIVALENT 3
SMITHS MEDICAL ASD INC
  SUBSTANTIALLY EQUIVALENT 1

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