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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthguard, prescription
510(k) Number K112868
Device Name DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
Original Applicant
DREAMGARD, INC.
1601 k street, nw
washington,  DC  20006
Original Contact suzan onel
Classification Product Code
MQC  
Date Received09/30/2011
Decision Date 01/19/2012
Decision substantially equivalent (SESE)
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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