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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device yoke assembly, medical gas
Regulation Description Medical gas yoke assembly.
Product CodeCAM
Regulation Number 868.6885
Device Class 1


Premarket Reviews
ManufacturerDecision
ELMED
  SUBSTANTIALLY EQUIVALENT 1
PENOX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

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