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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilizer, ethylene-oxide gas
Regulation Description Ethylene oxide gas sterilizer.
Product CodeFLF
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BEN VENUE LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  1.  K915682  STERRAD 100 STERILIZATION SYSTEM
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 2
Device displays error message 1
Changes in ambient temperature in device environment 1
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Oct-09-2012
2 Advanced Sterilization Products II Jun-15-2009

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