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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
Component falling 4
Split 4
Use of Device Issue 4
Detachment of device or device component 3
Crack 2
Torn material 1
Fitting problem 1
Installation-related problem 1
Component missing 1
Material integrity issue 1
Fracture 1
Total Device Problems 23

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