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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lamp, operating-room
Regulation Description Surgical lamp.
Product CodeFQP
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Split 2
Crack 2
Fracture 1
Use of Device Issue 1
Component falling 1
Detachment of device or device component 1
Installation-related problem 1
Material integrity issue 1
Total Device Problems 10

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