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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, surgical, instrument
Regulation Description Manual surgical instrument for general use.
Product CodeFSM
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HU-FRIEDY
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 5
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RILEY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 2
No Known Device Problem 2
Bent 1
Dull 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Mar-28-2013
2 Customed, Inc II Mar-21-2012

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