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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 K130538
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 Received03/01/2013
Decision Date 05/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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