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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K200770
Device Name Mini PCNL-System
Trokamed GmbH
Kleine Breite 17
Geisingen,  DE 78187
Applicant Contact Stefan Weiland
Trokamed GmbH
Kleine Breite 17
Geisingen,  DE 78187
Correspondent Contact Stefan Weiland
Regulation Number876.1500
Classification Product Code
Date Received03/25/2020
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No