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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 K011971
Device Name NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
Applicant
Image-Guided Neurologics, Inc.
2290 W. Eau Gallie Blvd.
Suite 210
Melbourne,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
Image-Guided Neurologics, Inc.
2290 W. Eau Gallie Blvd.
Suite 210
Melbourne,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/25/2001
Decision Date 08/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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