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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, floor standing
Regulation Description Surgical lamp.
Product CodeFSS
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ASTRON
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 1
LUCID, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical issue 4
Material disintegration 3
Detachment of device component 3
Burn of device or device component 2
Component falling 1
Other (for use when an appropriate device code cannot be identified) 1
Device operates differently than expected 1
Device inoperable 1
Self-activation or keying 1
Heat 1
Total Device Problems 18

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