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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adaptor, holder, syringe
Regulation Description Daily activity assist device.
Product CodeIQG
Regulation Number 890.5050
Device Class 1


Premarket Reviews
ManufacturerDecision
41 INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOOL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Total Device Problems 1

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