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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name duodenoscope and accessories, flexible/rigid
510(k) Number K201098
Device Name Ambu Duodeno System
Ambu Innovation GmbH
Peterhofstr 3b
Kissing,  DE 86438
Applicant Contact Oliver V Ruepprecht
Ambu Inc.
6230 Old Dobbin Lane Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received04/24/2020
Decision Date 07/17/2020
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