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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cold pack and vibrating massager
Definition Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
Product CodePHW
Regulation Number 890.5975
Device Class 1


Premarket Reviews
ManufacturerDecision
MMJ LABS, LLC
  SUBSTANTIALLY EQUIVALENT 2

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