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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 K153281
Device Name BrightMatter Guide with Surface Trace Registration
Applicant
Synaptive Medical, Inc.
Mars Center, S. Tower, 101 College St., Suite 200
Toronto,  CA M5G1L7
Applicant Contact Cameron Piron
Correspondent
Synaptive Medical, Inc.
Mars Center, S. Tower, 101 College St., Suite 200
Toronto,  CA M5G1L7
Correspondent Contact Cameron Piron
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/12/2015
Decision Date 03/30/2016
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
Recalls CDRH Recalls
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