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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 K003201
Device Name STEALTHSTATION TREATMENT GUIDANCE PLATFORM
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact RONALD K SMITH
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact RONALD K SMITH
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/12/2000
Decision Date 12/12/2000
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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