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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 K033813
Device Name MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
Applicant
Micrus Corp.
610 Palomar Ave.
Sunnyvale,  CA  94085
Applicant Contact MARGARET WEBBER
Correspondent
Micrus Corp.
610 Palomar Ave.
Sunnyvale,  CA  94085
Correspondent Contact MARGARET WEBBER
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/09/2003
Decision Date 02/04/2004
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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