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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 K130504
Device Name ASA ORAL APPLIANCES
Applicant
AMERICAN SLEEP ASSOCIATION
PO BOX 566
CHESTERLAND,  OH  44026 -2141
Applicant Contact KAREN E WARDEN, PHD
Correspondent
AMERICAN SLEEP ASSOCIATION
PO BOX 566
CHESTERLAND,  OH  44026 -2141
Correspondent Contact KAREN E WARDEN, PHD
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/27/2013
Decision Date 10/18/2013
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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