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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
Break 9
Detachment of device component 6
Material separation 5
Device, or device fragments remain in patient 2
Device Issue 1
Malfunction 1
Applicator failure 1
Detachment of device or device component 1
Total Device Problems 26

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