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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
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