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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, percutaneous, biopsy
Regulation Description Manual surgical instrument for general use.
Product CodeMJG
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), worn 1
Total Device Problems 1

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 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medical Device Technologies, Inc. II Oct-08-2010

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