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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 K051405
Device Name REGENSIS PERICARDIAL PATCH
Applicant
Cormatrix Cardiovascular, Inc.
155 Moffett Park Dr.
Sunnyvale,  CA  94089
Applicant Contact PUNAM GOLLAMUDI
Correspondent
Cormatrix Cardiovascular, Inc.
155 Moffett Park Dr.
Sunnyvale,  CA  94089
Correspondent Contact PUNAM GOLLAMUDI
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received05/31/2005
Decision Date 08/31/2005
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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