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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 K163580
Device Name ASD Oral Appliances
Applicant
AMERICAN SLEEP DENTISTRY
1957 WEST ROYAL HUNTE DRIVE
STE 250
CEDAR CITY,  UT  84720 -1903
Applicant Contact RYAN GREGERSON
Correspondent
AMERICAN SLEEP DENTISTRY
1957 WEST ROYAL HUNTE DRIVE
STE 250
CEDAR CITY,  UT  84720 -1903
Correspondent Contact RYAN GREGERSON
Regulation Number872.5570
Classification Product Code
LRK  
Date Received12/20/2016
Decision Date 06/08/2017
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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