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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 K112683
Device Name SMI CARDIOVASCULAR PACH
Original Applicant
SOLIMAS MEDICAL, INC.
443 costa mesa terrace
sunnyvale,  CA  94089
Original Contact micheal kolbe
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received09/15/2011
Decision Date 12/14/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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