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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device two or more sterilant sterilizer
Regulation Description Ethylene oxide gas sterilizer.
Definition Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
Product CodePJJ
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 1

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