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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K051817
Device Name BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
Applicant
Cardiva Medical, Inc.
P.O. Box 10925
Pleasanton,  CA  94588
Applicant Contact KARIN GASTINEAU
Correspondent
Cardiva Medical, Inc.
P.O. Box 10925
Pleasanton,  CA  94588
Correspondent Contact KARIN GASTINEAU
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/05/2005
Decision Date 12/06/2006
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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