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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K140306
Device Name CORMATRIX PROTECT ECM ENVELOPE
Applicant
CORMATRIX CARDIOVASCULAR, INC.
1100 OLD ELLIS ROAD
ROSWELL,  GA  30076
Applicant Contact BRYAN BROSSEAU
Correspondent
CORMATRIX CARDIOVASCULAR, INC.
1100 OLD ELLIS ROAD
ROSWELL,  GA  30076
Correspondent Contact BRYAN BROSSEAU
Regulation Number878.3300
Classification Product Code
FTM  
Date Received02/07/2014
Decision Date 08/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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