FDA 510(k) Application Details - K110085

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K110085
Device Name Display, Cathode-Ray Tube, Medical
Applicant ST. JUDE MEDICAL
ONE ST JUDE MEDICAL DRIVE
ST PAUL, MN 55117-9913 US
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Contact KRIS MILLER
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 01/11/2011
Decision Date 01/26/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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