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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 K120103
Device Name REST ASSURED GENERATION III DENTAL PROTECTOR
Original Applicant
RANIR LLC
555 thirteenth street, nw
washington,  DC  20004
Original Contact gerard j prud'homme
Classification Product Code
OBR  
Date Received01/12/2012
Decision Date 02/03/2012
Decision substantially equivalent (SE)
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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