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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device manual refractor, 3d display
Definition A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.
Product CodeSBI
Regulation Number 886.1770
Device Class 1


Premarket Reviews
ManufacturerDecision
EVOLUTION OPTIKS LIMITED
  SUBSTANTIALLY EQUIVALENT 1

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