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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 K924215
Device Name AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Applicant Contact DAVID LEE
Correspondent
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Correspondent Contact DAVID LEE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/04/1992
Decision Date 09/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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