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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K161656
FOIA Releasable 510(k) K161656
Device Name Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
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 Number874.4680
Classification Product Code
EOQ  
Date Received06/16/2016
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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