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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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More FDA Info for this Product Code
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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