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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 K231976
Device Name StealthStation Cranial Software, v3.1.5 (9735585)
Applicant
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Applicant Contact Rishi Mehta
Correspondent
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Rishi Mehta
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/03/2023
Decision Date 10/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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