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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 K132952
Device Name MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
Applicant
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN,  CA  92780
Applicant Contact LARAINE PANGELINA
Correspondent
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN,  CA  92780
Correspondent Contact LARAINE PANGELINA
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received09/19/2013
Decision Date 12/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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