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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 K063229
Device Name REST ASSURED NITE PROTECTOR
Applicant
Ranir, LLC
900 Fifth Third Center
111 Lyon St. NW
Grand Rapids,  MI  49503
Applicant Contact CHRISTOPHER PREDKO
Correspondent
Ranir, LLC
900 Fifth Third Center
111 Lyon St. NW
Grand Rapids,  MI  49503
Correspondent Contact CHRISTOPHER PREDKO
Classification Product Code
OBR  
Date Received10/25/2006
Decision Date 12/19/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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