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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 K191597
Device Name Stealth Autoguide System, Midas Rex Legend Depth Stop System
Applicant
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Jason Woehrle
Correspondent
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Jason Woehrle
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Codes
HBB   HBC   HBE  
Date Received06/17/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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