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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrumentation, surgical mesh, urogynecologic, transabdominal repair of pelvic organ prolapse
Regulation Description Specialized surgical instrumentation for use with urogynecologic surgical mesh.
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair
Product CodePWK
Regulation Number 884.4910
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1


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