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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, vestibular analysis
Product CodeLXV
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CLEARWATER CLINICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDICAA (URUGUAY) S.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 1 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acacia Engineered Products LLC II Sep-17-2008
2 Neuro Kinetics II Sep-30-2009

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