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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 K083191
Device Name DETLOGIX ANNULOPLASTY RING, MODEL: 5100
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Applicant Contact MARTIN A KAUFMAN
Correspondent
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Correspondent Contact MARTIN A KAUFMAN
Regulation Number870.3800
Classification Product Code
KRH  
Date Received10/29/2008
Decision Date 04/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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