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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 K121344
Device Name NU SLEEP
Original Applicant
22817 ventura blvd
woodland hills,  CA  91364
Original Contact daniela levy
Regulation Number872.5570
Classification Product Code
Date Received05/04/2012
Decision Date 10/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No