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510(k) K110713

WATERPAP VALVE by Airways Development, LLC — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2011
Date Received
March 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

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