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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device elastomer, silicone, for scar management
Regulation Description Silicone sheeting.
Product CodeMDA
Regulation Number 878.4025
Device Class 1


Premarket Reviews
ManufacturerDecision
ADVANCED BIO-TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
CUI CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTECH ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 2
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
NEWMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

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