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FDA 510(k), K063349, CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
FDA 510(k), K063349, CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
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510(K) Number: K063349
Device Name: CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 11/06/2006
Decision Date: 02/16/2007
Regulation Medical Specialty: Cardiovascular
Device Name: CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 11/06/2006
Decision Date: 02/16/2007
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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