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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dressing, wound, collagen
Product CodeKGN
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACELL, INC
  SUBSTANTIALLY EQUIVALENT 5
ADRI/TECHNAM
  SUBSTANTIALLY EQUIVALENT 1
AEON ASTRON EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 1
AUBREY GROUP
  SUBSTANTIALLY EQUIVALENT 1
BRENNEN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 5
COLLAMATRIX CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNOCOLL PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 4
INTEGRA
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORGANOGENESIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEGASUS
  SUBSTANTIALLY EQUIVALENT 2
SOUTHWEST TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 3
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Reaction 1
Total Device Problems 1

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