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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 K171947
Device Name SOLOASSIST II
Applicant
AKTORmed GmbH
Borsigstrabe 13
Barbing,  DE 93092
Applicant Contact Andreas Mohr
Correspondent
Micro-Epsilon America
8120 Browneigh Road
Raleigh,  NC  93092
Correspondent Contact Martin Dumberger
Regulation Number876.1500
Classification Product Code
NAY  
Date Received06/29/2017
Decision Date 09/21/2018
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
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