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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 K233886
Device Name Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Mette Andersen
Correspondent
Ambu Inc.
6721 Columbia Gateway Drive, Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
FET  
Date Received12/08/2023
Decision Date 04/16/2024
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
Predetermined Change
Control Plan Authorized		 No
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