FDA 510(k) Application Details - K133701

Device Classification Name

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510(K) Number K133701
Device Name NUVANT MCT SYSTEM
Applicant CORVENTIS, INC.
1410 ENERGY PARK DRIVE,
SUITE 1
ST. PAUL, MN 55108 US
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Contact CHERYL SWANSON
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Regulation Number

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Classification Product Code QYX
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Date Received 12/03/2013
Decision Date 02/06/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K133701


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