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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 K111187
Device Name PATCH, PLEDGET AND INTRACARDIAC
Original Applicant
CORMATRIX CARDIOVASCULAR, INC.
155 moffett park drive
suite 210
sunnyvale,  CA  94089
Original Contact kit cariquitan
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received04/27/2011
Decision Date 07/26/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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