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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device applicator, absorbent tipped, non-sterile
Regulation Description Absorbent tipped applicator.
Product CodeKXF
Regulation Number 880.6025
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Unraveled material 16
Break 10
Detachment of device component 7
Loss of or failure to bond 5
Material separation 5
Device, or device fragments remain in patient 2
Detachment of device or device component 2
No Known Device Problem 1
Energy output to patient tissue incorrect 1
Fire 1
Burn of device or device component 1
Device Issue 1
Malfunction 1
Applicator failure 1
Total Device Problems 54

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

Recalls
Manufacturer Recall Class Date Posted
1 Owens & Minor Distribution, Inc. II May-01-2013

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