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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K080178
Device Name VALVULOTOME BY KOVEN
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 Number870.4885
Classification Product Code
MGZ  
Date Received01/24/2008
Decision Date 07/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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