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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K163439
Device Name NaviENT
Applicant
ClaroNav Inc.
1140 Sheppard Avenue West - Unit 10
Toronto,  CA M3K 2A2
Applicant Contact Ahmad Kolahi
Correspondent
ClaroNav Inc.
1140 Sheppard Avenue West - Unit 10
Toronto,  CA M3K 2A2
Correspondent Contact Ahmad Kolahi
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/08/2016
Decision Date 09/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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