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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K010452
Device Name BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
Applicant
Koven Technology, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Applicant Contact J. HARVEY KNAUSS
Correspondent
Koven Technology, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/15/2001
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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