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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 K122105
Device Name SMI CARDIOVASCULAR PATCH
Applicant
SOLINAS MEDICAL INC
443 COSTA MESA TERRACE
SUNNY VALE,  CA  94089
Applicant Contact JAMES HONG
Correspondent
SOLINAS MEDICAL INC
443 COSTA MESA TERRACE
SUNNY VALE,  CA  94089
Correspondent Contact JAMES HONG
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/17/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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