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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K110962
Device Name AMBU ASCOPE 2
Applicant
Ambu A/S
6740 Baymeadow Dr.
Glen Burnie,  MD  21060
Applicant Contact SANJAY PARIKH
Correspondent
Ambu A/S
6740 Baymeadow Dr.
Glen Burnie,  MD  21060
Correspondent Contact SANJAY PARIKH
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/06/2011
Decision Date 11/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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