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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 K130067
Device Name MRNA APPLIANCE
Applicant
Biomodeling Solutions, Lls
15455 NW Greenbrier Pkwy.
Beaverton,  OR  97006
Applicant Contact COLETTE COZEAN, PH.D.
Correspondent
Biomodeling Solutions, Lls
15455 NW Greenbrier Pkwy.
Beaverton,  OR  97006
Correspondent Contact COLETTE COZEAN, PH.D.
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/10/2013
Decision Date 05/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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