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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, medical examination, ac powered
Regulation Description AC-powered medical examination light.
Product CodeKZF
Regulation Number 880.6320
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 1
BURTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 8
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
SKYTRON
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Unknown (for use when the device problem is not known) 3
Other (for use when an appropriate device code cannot be identified) 2
Burn of device or device component 1
No Information 1
Total Device Problems 7

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 Stryker Communications II Aug-21-2013

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