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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stand, instrument, ac-powered, ophthalmic
Regulation Description Ophthalmic instrument stand.
Product CodeHMF
Regulation Number 886.1860
Device Class 1


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component falling 1
Slippage of device or device component 1
Device operates differently than expected 1
Dislodged or dislocated 1
Total Device Problems 4

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