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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 K210700
Device Name NaviNetics D1 Stereotactic System
Applicant
NaviNetics, Inc
206 S Broadway, Suite 700
Rochester,  MN  55904
Applicant Contact Patrick Gora
Correspondent
NaviNetics, Inc
206 S Broadway, Suite 700
Rochester,  MN  55904
Correspondent Contact Patrick Gora
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/09/2021
Decision Date 06/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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