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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 K012719
Device Name NAVIGUS II MR
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/14/2001
Decision Date 10/22/2001
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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