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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K193095
Device Name Ambu aScope 4 Cysto
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Anita Fjaestad
Correspondent
Ambu Inc.
6230 Old Dobbin Lane, Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received11/07/2019
Decision Date 04/02/2020
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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