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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 K181116
Device Name CONVIVO
Applicant
Carl Zeiss Meditec AG
Goeschwitzer Str. 51-52
Jena,  DE 07745
Applicant Contact Christian Muenster
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin,  CA  94568
Correspondent Contact Mandy Ambrecht
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
OWN  
Date Received04/27/2018
Decision Date 10/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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