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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 K022100
Device Name NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
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 Received06/28/2002
Decision Date 09/25/2002
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
Recalls CDRH Recalls
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