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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rongeur, powered
Regulation Description Powered rongeur.
Product CodeHAD
Regulation Number 882.4845
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
PERSONAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 9
Detachment of device or device component 3
Difficult to open or close 2
Mechanical issue 1
Failure to align 1
Bent 1
Total Device Problems 17

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