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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 K993278
Device Name AMBU NEONATE SILICONE RESUSCITATOR
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Applicant Contact SANJAY PARIKH
Correspondent
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Correspondent Contact SANJAY PARIKH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/30/1999
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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