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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device optical neurosurgical nerve locator
Definition To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Product CodeQWP
Regulation Number 874.1820
Device Class 2


Premarket Reviews
ManufacturerDecision
WAYPOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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