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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 K992927
Device Name STEALTHSTATION TREATMENT GUIDANCE PLATFORM
Applicant
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact ANGELIQUE DESTRUEL
Correspondent
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact ANGELIQUE DESTRUEL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/31/1999
Decision Date 12/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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