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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 K162999
Device Name V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
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 Received10/28/2016
Decision Date 03/29/2017
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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