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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 K983539
Device Name TRAJECTORY GUIDE, MODEL # TGX-XXX
Applicant
Image-Guided Neurologics, Inc.
570 Hale Ave. N.
Oakdale,  MN  55128
Applicant Contact MICHAEL J RENNER
Correspondent
Image-Guided Neurologics, Inc.
570 Hale Ave. N.
Oakdale,  MN  55128
Correspondent Contact MICHAEL J RENNER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/09/1998
Decision Date 02/12/1999
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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