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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 K143420
Device Name SYMBIS Surgical System
Applicant
Imris, Inc.
5101 Shady Oak Rd.
Minnetonka,  MN  55343
Applicant Contact Sanjay Shah
Correspondent
Imris, Inc.
5101 Shady Oak Rd.
Minnetonka,  MN  55343
Correspondent Contact Sanjay Shah
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/28/2014
Decision Date 10/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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