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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intraoral pressure gradient device
510(k) Number K122130
Device Name WINX SLEEP THERAPY SYSTEM
Original Applicant
APNICURE, INC.
900 chesapeake dr
redwood city,  CA  94063
Original Contact chris daniel
Regulation Number872.5570
Classification Product Code
OZR  
Date Received07/18/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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