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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilizer automated loading system
Regulation Description Steam sterilizer.
Definition Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.
Product CodePEC
Regulation Number 880.6880
Device Class 2


Premarket Reviews
ManufacturerDecision
GETINGE
  SUBSTANTIALLY EQUIVALENT 1

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