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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 K022420
Device Name MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
Applicant
MICRUS CORP.
495 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MARGARET WEBBER
Correspondent
MICRUS CORP.
495 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MARGARET WEBBER
Regulation Number882.5950
Classification Product Code
HCG  
Date Received07/24/2002
Decision Date 10/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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