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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 K171661
Device Name Scopis Extended Instrument Set EM
Applicant
Scopis GmbH
Heinrich-Heine-Platz 10
Berlin,  DE 10719
Applicant Contact Christopher Özbek
Correspondent
Scopis GmbH
Heinrich-Heine-Platz 10
Berlin,  DE 10719
Correspondent Contact Christopher Özbek
Regulation Number882.4560
Classification Product Code
PGW  
Date Received06/05/2017
Decision Date 09/27/2017
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
Predetermined Change
Control Plan Authorized		 No
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