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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, powered
Regulation Description Powered table.
Product CodeINQ
Regulation Number 890.3760
Device Class 1


Premarket Reviews
ManufacturerDecision
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
HAUSMANN INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL LABORATORIES CO.
  SUBSTANTIALLY EQUIVALENT 10
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
Use of Device Issue 2
Device operates differently than expected 1
Unintended movement 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Phillips Nuclear Medicine II Jan-12-2011

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