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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 K161452
Device Name MicroPlex Coil System (MCS) - HyperSoft 3D
Applicant
MICROVENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Applicant Contact SAPNA SINGH
Correspondent
MICROVENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Correspondent Contact SAPNA SINGH
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received05/26/2016
Decision Date 08/31/2016
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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