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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 K091175
Device Name GRIND NO MORE VERSION 2 AND 3
Applicant
RANIR LLC
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
RANIR LLC
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Classification Product Code
OBR  
Date Received04/22/2009
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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