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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 K180854
Device Name Voyager Trajectory Array Guide (V-TAG)
Applicant
Voyager Therapeutics, Inc.
75 Sidney Street
Cambridge,  MA  02139
Applicant Contact Lynn E Bayless
Correspondent
Voyager Therapeutics, Inc.
75 Sidney Street
Cambridge,  MA  02139
Correspondent Contact Lynn E Bayless
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/02/2018
Decision Date 07/23/2018
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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