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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 K160766
Device Name Ambu USR, Ambu M
Applicant
AMBU A/S
BALTORPBAKKEN 13
BALLERUP,  DK DK-2750
Applicant Contact CAMILLA WISMAR
Correspondent
AMBU, INC.
6230 OLD DOBBIN LANE
SUITE 250
COLUMBIA,  MD  21045
Correspondent Contact SANJAY PARIKH
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received03/21/2016
Decision Date 08/17/2016
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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