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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drills, burrs, trephines and accessories (simple powered), reprocessed
Regulation Description Powered simple cranial drills, burrs, trephines, and their accessories.
Product CodeNLN
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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