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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device skin patch for treatment of hyperhidrosis
Definition A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.
Product CodeQVX
Regulation Number 878.4425
Device Class 2


Premarket Reviews
ManufacturerDecision
CANDESANT BIOMEDICAL, INC.
  GRANTED 1

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