FDA 510(k) Application Details - K131623

Device Classification Name Transducer, Ultrasonic

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510(K) Number K131623
Device Name Transducer, Ultrasonic
Applicant KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071-3404 US
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Contact HARVEY KNAUSS
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Regulation Number 870.2880

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Classification Product Code JOP
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Date Received 06/04/2013
Decision Date 01/17/2014
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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