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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intraoral cooling device
Definition An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces
Product CodeQUA
Regulation Number 872.5590
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINCOOL AB
  GRANTED 1
CHEMO MOUTHPIECE, LLC
  SUBSTANTIALLY EQUIVALENT 1

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