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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
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