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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 K980534
Device Name DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
Applicant
The Heart Valve Div. Medtronic Cardiovascular Surg
18011 S. Mitchell
Irvine,  CA  92714
Applicant Contact JEAN CHAMPION
Correspondent
The Heart Valve Div. Medtronic Cardiovascular Surg
18011 S. Mitchell
Irvine,  CA  92714
Correspondent Contact JEAN CHAMPION
Regulation Number870.3800
Classification Product Code
KRH  
Date Received02/11/1998
Decision Date 04/30/1998
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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