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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 (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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