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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system and accessories, isolated heart, transport and preservation
Regulation Description Isolated kidney perfusion and transport system and accessories.
Product CodeMSB
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 1
TRANSMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

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