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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, collagen, staple line reinforcement
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Product CodeOXE
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS SURGICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

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