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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
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