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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device air filter portable apparatus
Regulation Description Air-handling apparatus for a surgical operating room.
Definition The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Product CodeORC
Regulation Number 878.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
TOUL MEDITECH AB
  SUBSTANTIALLY EQUIVALENT 1

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