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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, laryngectomy
Regulation Description Ear, nose, and throat manual surgical instrument.
Product CodeKAC
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Blockage within device or device component 1
Device, removal of (non-implant) 1
Dislodged or dislocated 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD, Inc. III Jan-25-2007

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