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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K923976
Device Name AMBU SINGLE PATIENT USE PEEP VALVE
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 Number868.5965
Classification Product Code
BYE  
Date Received08/07/1992
Decision Date 01/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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