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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 K130382
Device Name HEARTSTRING III PROXIMAL SEAL SYSTEM
Applicant
Boston Scientific Corporation
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact MARK DINGER
Correspondent
Boston Scientific Corporation
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact MARK DINGER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/14/2013
Decision Date 06/05/2013
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
Recalls CDRH Recalls
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