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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, traction
Regulation Description Traction accessory.
Product CodeILZ
Regulation Number 890.5925
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Unintended collision 1
Total Device Problems 2

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