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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device media,coupling,ultrasound
Regulation Description Diagnostic ultrasonic transducer.
Product CodeMUI
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Pharmaceutical Innovations, Inc. I May-24-2012

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