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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diagnostic neurosurgical microscope filter
Definition A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.
Product CodeQFX
Regulation Number 882.4950
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 1
LEICA MICROSYSTEMS (SCHWEIZ) AG
  GRANTED 1

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