FDA 510(k) Application Details - K031931

Device Classification Name Flowmeter, Blood, Cardiovascular

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510(K) Number K031931
Device Name Flowmeter, Blood, Cardiovascular
Applicant KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071-3404 US
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Contact J. HARVEY KNAUSS
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Regulation Number 870.2100

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Classification Product Code DPW
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Date Received 06/23/2003
Decision Date 02/13/2004
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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