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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
Applicant
Rh Associates, LLC
22817 Ventura Blvd.
#161
Woodland Hills,  CA  91364
Applicant Contact DANIELA LEVY
Correspondent
Rh Associates, LLC
22817 Ventura Blvd.
#161
Woodland Hills,  CA  91364
Correspondent Contact DANIELA LEVY
Regulation Number872.5570
Classification Product Code
LRK  
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
Predetermined Change
Control Plan Authorized		 No
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