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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 K090317
Device Name BABI*PLUS BUBBLE PAP VALVE
Applicant
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Applicant Contact THOMAS C LOESCHER
Correspondent
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Correspondent Contact THOMAS C LOESCHER
Regulation Number868.5965
Classification Product Code
BYE  
Date Received02/09/2009
Decision Date 05/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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