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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 K140705
Device Name NAVIGABLE BRAIN BIOPSY CANNULA SET
Applicant
IZI MEDICAL PRODUCTS
5 EASTER COURT SUITE J
OWINGS MILLS,  MD  21117
Applicant Contact QIANG CAO
Correspondent
IZI MEDICAL PRODUCTS
5 EASTER COURT SUITE J
OWINGS MILLS,  MD  21117
Correspondent Contact QIANG CAO
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/21/2014
Decision Date 12/05/2014
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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