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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 K092310
Device Name SEGUIN ANNULOPLASTY RING
Applicant
St Jude Medical
177 E. County Rd. B
St.Paul,  MN  55117
Applicant Contact THOMAS RADEMACHER
Correspondent
St Jude Medical
177 E. County Rd. B
St.Paul,  MN  55117
Correspondent Contact THOMAS RADEMACHER
Regulation Number870.3800
Classification Product Code
KRH  
Date Received07/29/2009
Decision Date 08/27/2009
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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