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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 K183325
Device Name Modus Nav
Applicant
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto,  CA M5V 3B1
Applicant Contact Maham Ansari
Correspondent
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto,  CA M5V 3B1
Correspondent Contact Maham Ansari
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/30/2018
Decision Date 07/14/2019
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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