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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chamber, patient isolation
Regulation Description Patient care reverse isolation chamber.
Product CodeLGM
Regulation Number 880.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENTEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1

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