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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 K161491
Device Name Scopis Hybrid Navigation System EM
Scopis GmbH
Heinrich-Heine-Platz 10
Berlin,  DE 10179
Applicant Contact Christopher Ozbek
Phiama, Inc
236 McKinley Park Lane
Louisville,  CO  80027
Correspondent Contact Roger White
Regulation Number882.4560
Classification Product Code
Date Received06/01/2016
Decision Date 02/09/2017
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