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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microscope, specular
Regulation Description AC-powered slitlamp biomicroscope.
Definition Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Product CodeNQE
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
KONAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 2

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