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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 K062036
Device Name MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
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 Received07/19/2006
Decision Date 08/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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