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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device non-stainless steel needle
Regulation Description Hypodermic single lumen needle.
Definition A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use.
Product CodePVZ
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

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