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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 K190672
Device Name StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
Applicant
Medtronic Navigation, Inc.
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact Elizabeth Waite
Correspondent
Medtronic Navigation, Inc.
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact Elizabeth Waite
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/15/2019
Decision Date 07/31/2019
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
Recalls CDRH Recalls
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