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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 K050438
Device Name STEALTHSTATION SYSTEM UPDATE
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Applicant Contact TINA DREILING
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Correspondent Contact TINA DREILING
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/22/2005
Decision Date 06/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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