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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 K110713
Device Name WATERPAP VALVE
Applicant
AIRWAYS DEVELOPMENT, LLC
P.O. BOX 558
CEDAR KNOLLS,  NJ  07927
Applicant Contact RICHARD J LARKIN
Correspondent
AIRWAYS DEVELOPMENT, LLC
P.O. BOX 558
CEDAR KNOLLS,  NJ  07927
Correspondent Contact RICHARD J LARKIN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received03/15/2011
Decision Date 09/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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