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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, nose, internal
Regulation Description Nose prosthesis.
Product CodeFZE
Regulation Number 878.3680
Device Class 2


Premarket Reviews
ManufacturerDecision
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CUI CORP.
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 1
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
IMPLANTECH ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 7
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 1
SILIMED
  SUBSTANTIALLY EQUIVALENT 1

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