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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 K030106
Device Name STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact VICTORIA G RENDON
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact VICTORIA G RENDON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/13/2003
Decision Date 02/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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