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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 K142024
FOIA Releasable 510(k) K142024
Device Name BRIGHTMATTER NAVIGATION SYSTEM
Applicant
SYNAPTIVE MEDICAL INC.
MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200
TORONTO,  CA M5G1L7
Applicant Contact CAMERON PIRON
Correspondent
SYNAPTIVE MEDICAL INC.
MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200
TORONTO,  CA M5G1L7
Correspondent Contact CAMERON PIRON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/25/2014
Decision Date 04/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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