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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tampon, menstrual, scented, deodorized
Regulation Description Scented or scented deodorized menstrual tampon.
Product CodeHIL
Regulation Number 884.5460
Device Class 2


Premarket Reviews
ManufacturerDecision
FIRST QUALITY HYGIENIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
PERSONAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 6
PLAYTEX PRODUCTS, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 2
  SUBSTANTIALLY EQUIVALENT 22
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 4
ROSTAM LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAMBRANDS MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 13

Device Problems
Patient-device incompatibility 1
Total Device Problems 1

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