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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, breast, external, used with adhesive
Regulation Description External aesthetic restoration prosthesis.
Product CodeKCZ
Regulation Number 878.3800
Device Class 1


Premarket Reviews
ManufacturerDecision
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 2
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 1

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