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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
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
NIMBIC SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
NIMBIC SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SURGICUBE INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
TOUL MEDITECH AB
  SUBSTANTIALLY EQUIVALENT 3

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