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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ear, nose, and throat stereotaxic instrument
510(k) Number K200723
Device Name StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
Applicant
Medtronic Navigation Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact Carey Brenner
Correspondent
Medtronic Navigation Inc.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact Carey Brenner
Regulation Number882.4560
Classification Product Code
PGW  
Date Received03/19/2020
Decision Date 06/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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