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510(k) K111191

AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE by Wet Nose Technologies, LLC — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2011
Date Received
April 28, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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