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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, non-resorbable, orthopedics, reinforcement of ligament
Regulation Description Surgical mesh.
Definition a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
Product CodeQUW
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
THERAMICRO
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

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