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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 K984435
Device Name MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
Applicant
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Applicant Contact JULIE SHERMAN
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Minneapolis,  MN  55432 -3576
Correspondent Contact JULIE SHERMAN
Regulation Number870.3800
Classification Product Code
KRH  
Date Received12/11/1998
Decision Date 01/07/1999
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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