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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device headrest, neurosurgical
Regulation Description Neurosurgical headrests.
Product CodeHBM
Regulation Number 882.4440
Device Class 1


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Disengaged 1
Fire 1
Head immobilizer failure 1
Device operates differently than expected 1
No Known Device Problem 1
Total Device Problems 5

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