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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 K210883
Device Name aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Gurpreet Kaur Rehal
Correspondent
Ambu Inc.
6230 Old Dobbin Lane, Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received03/25/2021
Decision Date 06/17/2021
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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