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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 K080379
Device Name MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
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 Number882.5950
Classification Product Code
HCG  
Date Received02/13/2008
Decision Date 06/30/2008
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
Recalls CDRH Recalls
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