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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K170667
Device Name QEVO System with KINEVO 900
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact Christian Muenster
Correspondent
Biologics Consulting
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number882.1480
Classification Product Code
GWG  
Date Received03/06/2017
Decision Date 08/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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