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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K190972
Device Name Ambu aScope 4 RhinoLaryngo Intervention
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Gurpreet Kaur Rehal
Correspondent
Ambu, Inc.
6230 Old Dobbin Ln. Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Code
EOQ  
Date Received04/15/2019
Decision Date 07/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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