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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K033736
Device Name MERCI RETRIEVER, MODELS 90065, 90066
Applicant
Concentric Medical, Inc.
1380 Shorebird Way
Mountain View,  CA  94043
Applicant Contact KEVIN F MACDONALD
Correspondent
Concentric Medical, Inc.
1380 Shorebird Way
Mountain View,  CA  94043
Correspondent Contact KEVIN F MACDONALD
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/28/2003
Decision Date 08/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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