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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
Applicant
Scopis GmbH
Heinrich-Heine-Platz 10
Berlin,  DE 10179
Applicant Contact Christopher Ozbek
Correspondent
Phiama, Inc
236 McKinley Park Lane
Louisville,  CO  80027
Correspondent Contact Roger White
Regulation Number882.4560
Classification Product Code
PGW  
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
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