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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K083922
Device Name MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
Applicant
Micrus Endovascular Corporation
821 Fox Lane
San Jose,  CA  95131
Applicant Contact PATRICK LEE
Correspondent
Micrus Endovascular Corporation
821 Fox Lane
San Jose,  CA  95131
Correspondent Contact PATRICK LEE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/31/2008
Decision Date 05/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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