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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device brush, scrub, operating-room
Regulation Description Manual surgical instrument for general use.
Product CodeGEC
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 6
Material fragmentation 1
Material integrity issue 1
Total Device Problems 8

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