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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K082139
Device Name EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Applicant Contact DARYL RICHARDSON
Correspondent
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Correspondent Contact DARYL RICHARDSON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/29/2008
Decision Date 10/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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