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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 K190687
Device Name Twilite Appliance
Applicant
Stephen J Harkins, Dds, PC
4781 E. Camp Lowell Dr., #101
Tucson,  AZ  85712
Applicant Contact Stephen Harkins
Correspondent
Stephen J Harkins, Dds, PC C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/18/2019
Decision Date 07/02/2019
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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