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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
Applicant
Apnicure, Inc.
900 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact CHRIS DANIEL
Correspondent
Apnicure, Inc.
900 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact CHRIS DANIEL
Regulation Number872.5570
Classification Product Code
OZR  
Date Received07/18/2012
Decision Date 10/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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