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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K152915
Device Name EYE-SYNC
Applicant
SyncThink, Inc.
54 Canal Street Suite 200
Boston,  MA  02114
Applicant Contact Daniel Beeler
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number882.1460
Classification Product Code
GWN  
Date Received10/02/2015
Decision Date 01/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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