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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 K001153
Device Name MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
Applicant
MEDTRONIC SURGICAL NAVIGATION
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact VICTORIA RENDON
Correspondent
MEDTRONIC SURGICAL NAVIGATION
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact VICTORIA RENDON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/10/2000
Decision Date 05/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
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