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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 K142344
Device Name DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
Applicant
Izi Medical Products, LLC
5 Easter Ct Suite J
Owings Mills,  MD  21117
Applicant Contact QIANG CAO
Correspondent
Izi Medical Products, LLC
5 Easter Ct Suite J
Owings Mills,  MD  21117
Correspondent Contact QIANG CAO
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/22/2014
Decision Date 03/20/2015
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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