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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 K033685
Device Name NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
Applicant
Medical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights,  MN  55077
Applicant Contact DENNY STEGER
Correspondent
Medical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights,  MN  55077
Correspondent Contact DENNY STEGER
Regulation Number870.3800
Classification Product Code
KRH  
Date Received11/24/2003
Decision Date 08/03/2004
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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