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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 K153594
Device Name MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
Applicant
MICROVENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Applicant Contact Laraine Pangelina
Correspondent
MICROVENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Correspondent Contact Laraine Pangelina
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/16/2015
Decision Date 01/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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