FDA 510(k) Application Details - K131272

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K131272
Device Name Display, Cathode-Ray Tube, Medical
Applicant MEDUSA MEDICAL TECHNOLOGIES INC.
816 CONGRESS AVE.
SUITE 1400
AUSTIN, TX 78701 US
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Contact DIANE SUDDUTH
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 05/03/2013
Decision Date 01/03/2014
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 N
Expedited Review



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