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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K212382
Device Name Ambu® aScope™ Gastro, Ambu® aBox™2
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Mette Anderson
Correspondent
Ambu Inc.
6230 Old Dobbin Lane, Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FET  
Date Received08/02/2021
Decision Date 02/03/2022
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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