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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Over-The-Counter
510(k) Number K133423
Device Name REST ASSURED EXTRA COMFORT NITE PROTECTOR
Applicant
Ranir, LLC
4701 E. Paris Ave. SE
Grand Rapids,  MI  49512
Applicant Contact PAULA BOJSEN
Correspondent
Ranir, LLC
4701 E. Paris Ave. SE
Grand Rapids,  MI  49512
Correspondent Contact PAULA BOJSEN
Classification Product Code
OBR  
Date Received11/08/2013
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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