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FDA 510(k) Application Details - K131623
Device Classification Name
Transducer, Ultrasonic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2880
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Classification Product Code
JOP
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More FDA Info for this Product Code
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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