FDA 510(k) Application Details - K073372

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K073372
Device Name Display, Cathode-Ray Tube, Medical
Applicant SYSTEMSONE
6130 BLACKBERRY ST
STE B
ANCHORAGE, AK 99502 US
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Contact THOMAS ARTHUR
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 12/03/2007
Decision Date 12/07/2007
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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