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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K073004
Device Name SOMNOMED BFLEX
Applicant
Somnomed, Inc.
3537 Teasley Lane
Denton,  TX  76210
Applicant Contact ASHLEY TRUITT
Correspondent
Somnomed, Inc.
3537 Teasley Lane
Denton,  TX  76210
Correspondent Contact ASHLEY TRUITT
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
EBI  
Date Received10/24/2007
Decision Date 01/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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