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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, anti-snoring
510(k) Number K113022
Device Name PURESLEEP
Original Applicant
SLEEP SCIENCE PARTNERS, INC.
900 larkspur landing circle
suite 207
larkspur,  CA  94939
Original Contact heather flick
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/11/2011
Decision Date 06/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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