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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 K020434
Device Name MICROPLEX COIL SYSTEM (MCS)
Original Applicant
MICROVENTION, INC.
72 argonaut
aliso viejo,  CA  92656 1408
Original Contact vincent cutarelli
Regulation Number882.5950
Classification Product Code
HCG  
Date Received02/08/2002
Decision Date 07/29/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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