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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 Ste J
Owings Mills,  MD  21117
Applicant Contact QIANG CAO
Correspondent
IZI MEDICAL PRODUCTS LLC
5 Easter Ct Ste 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
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