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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
510(k) Number K060651
Device Name PROXIS SYSTEM, MODEL EPS101
Applicant
St Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove,  MN  55311
Applicant Contact KIMBERLY BRIGGS
Correspondent
St Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove,  MN  55311
Correspondent Contact KIMBERLY BRIGGS
Regulation Number870.1250
Classification Product Code
NFA  
Date Received03/13/2006
Decision Date 09/13/2006
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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