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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 K963173
Device Name STEALTHSTATION SYSTEM
Applicant
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact KURT SMITH, PH.D.
Correspondent
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact KURT SMITH, PH.D.
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/14/1996
Decision Date 10/25/1996
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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