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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurosurgical paddie
Regulation Description Neurosurgical paddie.
Product CodeHBA
Regulation Number 882.4700
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 61
Break 4
Detachment of device or device component 2
Tears, rips, holes in device, device material 2
Performance 1
Total Device Problems 70

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

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II Oct-20-2010

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