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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device a chemical vapor sterilization multivariable chemical indicator
Regulation Description Sterilization process indicator.
Definition A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Product CodeQKM
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERRAGENE S.A.
  SUBSTANTIALLY EQUIVALENT 1

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