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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K102824
Device Name AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
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 Number868.5915
Classification Product Code
BTM  
Date Received09/29/2010
Decision Date 01/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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