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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 K091792
Device Name REST ASSURED GENERATION II DENTAL PROTECTOR
Applicant
Ranir Corporation
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JEFF FISHER
Correspondent
Ranir Corporation
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JEFF FISHER
Classification Product Code
OBR  
Date Received06/17/2009
Decision Date 07/08/2009
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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