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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K053065
Device Name FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
Applicant
Bryan Keropian Dds
18607 Ventura Blvd., Suite 206
Tarzana,  CA  91356
Applicant Contact BRYAN KEROPIAN
Correspondent
Bryan Keropian Dds
18607 Ventura Blvd., Suite 206
Tarzana,  CA  91356
Correspondent Contact BRYAN KEROPIAN
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received11/01/2005
Decision Date 01/03/2006
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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