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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 K974161
Device Name STEALTHSTATION SYSTEM
Applicant
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact DAVID A MIRE
Correspondent
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact DAVID A MIRE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/27/1997
Decision Date 11/21/1997
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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