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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, orthopaedics, reinforcement of tendon
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in tendon repair.
Product CodeOWY
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1

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