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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 K073324
Device Name MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
Applicant
MEDTRONIC INC.
8299 CENTRAL AVENUE NE
MINNEAPOLIS,  MN  55432
Applicant Contact BECKY HANNACK
Correspondent
MEDTRONIC INC.
8299 CENTRAL AVENUE NE
MINNEAPOLIS,  MN  55432
Correspondent Contact BECKY HANNACK
Regulation Number870.3800
Classification Product Code
KRH  
Date Received11/27/2007
Decision Date 03/13/2008
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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