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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
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