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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electromechanical tear stimulator
Regulation Description Electromechanical tear stimulator.
Definition This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
Product CodeQKV
Regulation Number 886.5305
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPIC OPHTHALMICS
  SUBSTANTIALLY EQUIVALENT 1

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