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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 K140789
Device Name CORMATRIX ECM FOR VASCULAR REPAIR
Applicant
Cormatrix Cardiovascular, Inc.
1100 Old Ellis Rd.
Roswell,  GA  30076
Applicant Contact BRYAN BROSSEAU
Correspondent
Cormatrix Cardiovascular, Inc.
1100 Old Ellis Rd.
Roswell,  GA  30076
Correspondent Contact BRYAN BROSSEAU
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received03/31/2014
Decision Date 07/15/2014
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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