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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 K001284
Device Name STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact VICTORIA RENDON
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact VICTORIA RENDON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/21/2000
Decision Date 06/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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