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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, electro-acupuncture
510(k) Number K140530
Device Name Electro Auricular Device
Applicant
NAVIGANT CONSULTING, INC.
30 S WACKER DRIVE
SUITE 3100
CHICAGO,  IL  60606
Applicant Contact COLLEEN HITTLE
Correspondent
NAVIGANT CONSULTING, INC.
30 S WACKER DRIVE
SUITE 3100
CHICAGO,  IL  60606
Correspondent Contact COLLEEN HITTLE
Classification Product Code
BWK  
Date Received03/04/2014
Decision Date 10/02/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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