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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
Applicant
Ambu Innovation GmbH
Peterhofstr 3b
kissing,  DE 86438
Applicant Contact oliver v ruepprecht
Correspondent
Ambu Inc.
6230 Old Dobbin Lane Suite 250
columbia,  MD  21045
Correspondent Contact sanjay parikh
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
FET  
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
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