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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 K022363
Device Name SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
Applicant
St. Jude Medical, Inc.
One Lillehei Plz.
St. Paul,  MN  55117
Applicant Contact WILLIAM MCKELVY
Correspondent
St. Jude Medical, Inc.
One Lillehei Plz.
St. Paul,  MN  55117
Correspondent Contact WILLIAM MCKELVY
Regulation Number870.3800
Classification Product Code
KRH  
Date Received07/22/2002
Decision Date 09/19/2002
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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