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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 K002056
Device Name MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
Applicant
MICRUS CORP.
495 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact TOM HOLDYCH
Correspondent
MICRUS CORP.
495 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact TOM HOLDYCH
Regulation Number882.5950
Classification Product Code
HCG  
Date Received07/06/2000
Decision Date 01/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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