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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 K102909
Device Name SOMNOBRUX SPLINTS
Applicant
SOMNOMED INC
7460 WARREN PARKWAY
SUITE 190
FRISCO,  TX  75034
Applicant Contact BRADLEY SOUTHWORTH
Correspondent
SOMNOMED INC
7460 WARREN PARKWAY
SUITE 190
FRISCO,  TX  75034
Correspondent Contact BRADLEY SOUTHWORTH
Classification Product Code
MQC  
Date Received10/01/2010
Decision Date 12/13/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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