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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intranasal electrostimulation device for dry eye symptoms
Definition This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
Product CodeQBR
Regulation Number 886.5310
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLERGAN
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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