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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K073442
Device Name MICRUS MICROCOIL SYSTEMS
Applicant
Micrus Endovascular Corporation
821 Fox Lane
San Jose,  CA  95131
Applicant Contact JULIA GROSS
Correspondent
Micrus Endovascular Corporation
821 Fox Lane
San Jose,  CA  95131
Correspondent Contact JULIA GROSS
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/07/2007
Decision Date 02/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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