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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K080583
Device Name MODIFIED HD GUIDE CATHETER
Original Applicant
CONCENTRIC MEDICAL, INC.
301 e. evelyn ave.
mountain view,  CA  94041
Original Contact laraine pangelina
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/03/2008
Decision Date 07/18/2008
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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