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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 K983670
Device Name STEALTHSTATION SYSTEM
Applicant
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact ROGER WHITE
Correspondent
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact ROGER WHITE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/19/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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