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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 needle, single lumen, hypodermic
Regulation Description Hypodermic single lumen needle.
Definition A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.
Product CodeQNS
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TSK LABORATORY INTERNATIONAL JAPAN KK
  SUBSTANTIALLY EQUIVALENT 1

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