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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue adhesive for the topical approximation of skin
Regulation Description Tissue adhesive.
Definition Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Product CodeMPN
Regulation Number 878.4010
Device Class 2


Premarket Reviews
ManufacturerDecision
ADHEZION BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
CHEMENCE MEDICAL PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
1 0 0 0 0 0 0

Device Problems
Reaction 76
Other (for use when an appropriate device code cannot be identified) 73
Unknown (for use when the device problem is not known) 3
Material perforation 1
Total Device Problems 153

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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