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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument
510(k) Number K200473
Device Name SoloAsisst II, Voice Control
Applicant
Aktormed GmbH
Borsigstraße 13
Barbing,  DE 93092
Applicant Contact Andreas Mohr
Correspondent
Micro-Epsilon America
8120 Browneigh Rd.
Raleigh,  NC  27617
Correspondent Contact Martin Dumberger
Regulation Number876.1500
Classification Product Code
NAY  
Date Received02/26/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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