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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K092876
Device Name SJM ATTUNE ANNULOPLASTY RING
Applicant
ST. JUDE MEDICAL
177 EAST COUNTY ROAD B
ST. PAUL,  MN  55117
Applicant Contact THOMAS TADEMACHER
Correspondent
ST. JUDE MEDICAL
177 EAST COUNTY ROAD B
ST. PAUL,  MN  55117
Correspondent Contact THOMAS TADEMACHER
Regulation Number870.3800
Classification Product Code
KRH  
Date Received09/18/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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