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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 K112879
Device Name REST ASSURED READY TO WEAR NITE PROTECTOR
Applicant
RANIR LLC
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
RANIR LLC
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Classification Product Code
OBR  
Date Received09/30/2011
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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